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Kalt Micro Needle Holder Straight - With Lock 13.5 cm - 5 1/4" Stainless Steel
EUDAMEDClass I (EU MDR)
Ref SU-246-14
Identity
- Trade Name
- Kalt Micro Needle Holder Straight - With Lock 13.5 cm - 5 1/4" Stainless Steel EUDAMED
- Device Name
- Wiring & Suturing Instruments & Guides EUDAMED
- Model / Reference
- SU-246-14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055445932572 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
Kalt Micro Needle Holder Straight - With Lock 13.5 cm - 5 1/4" Stainless Steel 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 671f972e-9d0c-41e8-9e31-ca63270eee30 61 fields · synced Jun 18, 2026