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Infinex Onyx RH Micro Needle Holder With Lock Straight 18 cm - 7" Stainless Ste…
EUDAMEDClass I (EU MDR)
Ref SU-242-18 X
Identity
- Trade Name
- Infinex Onyx RH Micro Needle Holder With Lock Straight 18 cm - 7" Stainless Steel EUDAMED
- Device Name
- Wiring & Suturing Instruments & Guides EUDAMED
- Model / Reference
- SU-242-18 X EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056111357415 EUDAMED
- Basic UDI-DI
- 50554459WIRESUTUREWG EUDAMED
- EMDN Code
- L0205 NEEDLE HOLDERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Suturing needle holder, reusable
Infinex Onyx RH Micro Needle Holder With Lock Straight 18 cm - 7" Stainless Ste… by Surtex Instruments Ltd — Class I — MDR — listed in EUDAMED
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 50554459WIRESUTUREWG | Class I | Active |
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Manufacturer
- Manufacturer
- Surtex Instruments Ltd
- EUDAMED SRN
- GB-MF-000023183
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 99ae4f20-a2f4-4d28-a200-6adc9df7ba8b 61 fields · synced Oct 6, 2026