ANITEX Medical Components
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Component supplier · Injection moulding & assembly · Poland (EU)

Precision Manufacturing for the Medical Industry

Reliable production. Documented quality. European manufacturing. Components and sub-assemblies made to your specification — under your quality system.

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Anitex is a component supplier. We manufacture to your documentation; device certification remains with you.

Illustrative: typical plastic components for medical devices
Illustrative: typical plastic components for medical devices
injection moulding machines
33
clamping force
22–600 t
in operation since
1983
  • ISO 9001ISO 9001:2015, certified since 2022
  • Technical polymersPC, PC/ABS, PP, PA (+GF) · CoC/CoA documentation
  • Batch traceabilityResin lot → production batch → shipment
  • Production in the EULgota near Kłobuck, Silesia — same time zone as DACH
  • 40+ years experience (since 1983)
  • ISO 9001 certified
  • EU production
  • NDA available
  • Prototype → serial production

01Applications

What we manufacture

Plastic components and sub-assemblies for:

  • Medical equipment housings

    Medical equipment housings

    Class-A surfaces, disinfectant-resistant materials

  • Diagnostic equipment components

    Diagnostic equipment components

    Covers, frames and functional parts to your drawing

  • Laboratory equipment parts

    Laboratory equipment parts

    Technical parts in PC, PC/ABS, PP, PA (+GF)

  • Rehabilitation product components

    Rehabilitation product components

    Structural and visible parts, prototype to serial volumes

  • Disposable device components

    Disposable device components

    Parts not requiring clean production, to your drawing

  • Sub-assembly & component integration

    Sub-assembly & component integration

    Assembly of moulded parts and inserts, packed to your instruction

These are applications of the components we supply — not finished medical devices.

02Capabilities in numbers

Capabilities

Machine park, tooling, materials and metrology — the figures your supplier assessment asks for.

  • Injection Moulding

    22–600 t

    clamping force

    33 machines · Welltec, Haitian, Wittmann Battenfeld, Yizumi · built 2003–2021

  • Toolshop

    8

    toolroom machines

    3 CNC machining centres, 2 die-sinking EDM, wire-cut EDM, surface grinder, CNC lathe

  • Tooling

    In-house

    toolshop

    Mould development, maintenance and repairs — customer-owned moulds serviced in-house

  • Materials

    PC · PC/ABS · PP · PA (+GF)

    technical polymers

    Processed to your material specification · CoC/CoA with every lot

  • Production Scale

    Prototype → series

    production scale

    Sample runs, pilot series and serial production on call-off schedules

  • Quality Control

    100%

    documented inspection of every batch

    CMM measurement, 3D scanning, measurement report with each delivery

Machine park

Injection moulding machines from 22 t to 600 t and the toolshop — all at the Lgota plant.

Welltec TTI-22HSE · 22 t clamping force
Welltec TTI-22HSE · 22 t clamping force
Wittmann Battenfeld SmartPower 350/3400 · 350 t
Wittmann Battenfeld SmartPower 350/3400 · 350 t
Welltec 500SeII · 500 t
Welltec 500SeII · 500 t
Welltec TTI-600SE · 600 t
Welltec TTI-600SE · 600 t
Wemas VZ-1250 · vertical machining centre, toolshop
Wemas VZ-1250 · vertical machining centre, toolshop
GF Agie Charmilles FORM P 600 · die-sinking EDM, toolshop
GF Agie Charmilles FORM P 600 · die-sinking EDM, toolshop
Agie Charmilles FORM 30 · die-sinking EDM, toolshop
Agie Charmilles FORM 30 · die-sinking EDM, toolshop
Agie Charmilles CUT 30 P · wire-cut EDM, toolshop
Agie Charmilles CUT 30 P · wire-cut EDM, toolshop

03Process + status

Medical Quality

What is in place today — documented and repeatable.

Process: from RFQ to delivery

  1. 01

    RFQ

    Drawing, 3D data, volumes. Feedback within 48 hours.

  2. 02

    Technical Review

    DFM, material selection, tool concept.

  3. 03

    Tooling

    Mould development and maintenance.

  4. 04

    Validation

    FAI / PPAP-ISIR. IQ/OQ/PQ to your protocols.

  5. 05

    Production

    Released process under change control.

  6. 06

    Quality Control

    CMM reports, documented inspection of every batch.

  7. 07

    Delivery

    CoC/CoA and batch data with the shipment.

  • Batch traceability Resin lot → part → shipment.
  • Material documentation CoC / CoA.
  • First article approval FAI / PPAP-ISIR.
  • Measurement reports CMM.
  • Change control No change to material, process or tool without your written approval.
  • Validation Ready for IQ/OQ/PQ according to your protocols.
  • Complaints 8D procedure.

Certification status

  1. In place

    ISO 9001:2015

    Certified since June 2022 · certification body Q&R Polska (PCA-accredited) · scope: design and production of injection-moulded parts; design and production of injection moulds, dies and other tooling; assembly of plastic component sub-assemblies and mechanisms.

    Download certificate (PDF)

Not in scope today: ISO 13485 certification, cleanroom production, biocompatibility testing. Device certification remains with the customer.

Why Anitex?

We have 43 years of process discipline in demanding industrial projects and open production capacity. Our first medical customers get priority capacity and direct board-level attention. Device certification remains with you — our job is a repeatable, documented process.

04Reference projects

Proven in demanding industries. The same rigor — now for medical.

Three anonymised project profiles from industrial series production — representative examples of the volumes, tooling and inspection regime we run.

Two-part control enclosure (industrial automation)

Two-part control enclosure (industrial automation)

Material
PC/ABS, flame retardant UL 94 V-0, textured surface VDI 3400 Ref. 27
Annual volume
120,000 sets/year (base + lid), call-offs every 2 weeks
Tool
2 customer-owned moulds, single-cavity, 160 t and 220 t machines, maintained in-house
Tolerances
±0.05 mm on the gasket groove, ±0.15 mm general (DIN 16742 TG 5)
Quality control
100% visual, gasket-groove gauge on every batch, CMM sampling per ISO 2859-1 (AQL 1.0), measurement report with each delivery
Delivery
Germany (Bavaria), 24-hour transit, returnable packaging
Fan impeller with ring housing (ventilation units)

Fan impeller with ring housing (ventilation units)

Material
PA6 GF30, heat-stabilised, brass insert in the hub
Annual volume
140,000 impellers/year + 140,000 rings/year
Tool
Impeller: customer-owned 2-cavity mould with balanced hot runner; ring: single-cavity, 160 t machines
Tolerances
Hub bore ±0.03 mm, blade tip runout ≤0.2 mm
Quality control
100% visual, insert pull-out test per batch, CMM sampling, dynamic balance check on first-off and every tool change
Delivery
Austria, weekly, in trays with layer separators
Ribbed structural tray, 500 × 380 mm (industrial equipment)

Ribbed structural tray, 500 × 380 mm (industrial equipment)

Material
PP copolymer, 20% talc-filled (PP-T20), UV-stabilised
Annual volume
100,000 pcs/year
Tool
Customer-owned single-cavity mould, 4-drop hot runner, 600 t machine (Welltec TTI-600SE)
Tolerances
±0.3 mm over 500 mm, flatness ≤1.0 mm
Quality control
100% visual, flatness check on a reference plate every shift, CMM sampling per batch, weight control ±1%
Delivery
Netherlands, two full-truck loads per month

05People

Who runs your project

Named contacts, not a ticket system.

Anitex plant, Lgota near Kłobuck, Poland
Anitex plant, Lgota near Kłobuck, Poland

EU-based nearshoring: production in southern Poland, a single truck-day from Germany and Austria. Short supply chains, same time zone, English- and German-speaking project team, flexible batch sizes.

06RFQ

Start Your Medical Manufacturing Project

Send us your drawing. We'll tell you within 48 hours whether and how we can manufacture it.

Upload CAD or drawing (optional)

    NDA available before any documentation is shared.

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    07Buyer FAQ

    Questions buyers ask first

    Do you have ISO 13485?

    Not yet. We are certified to ISO 9001:2015 (since 2022) and manufacture under your quality system and your quality agreement.

    Do you have a cleanroom?

    No — our focus is components not requiring clean production.

    Who certifies the device?

    The customer. We supply components and sub-assemblies to specification with full documentation: CoC/CoA, FAI / PPAP-ISIR, measurement reports, batch traceability. Anitex is not the manufacturer of the medical device.

    How does change control work?

    Every proposed change to material, process or tool is submitted to you in writing before implementation. Nothing changes without your written approval. After approval the change is documented and the affected characteristics are re-inspected.

    Do you build your own tools?

    Yes. Our in-house toolshop builds, maintains and repairs the moulds: CNC machining centres, die-sinking and wire-cut EDM, surface grinding, CNC turning.