Identity
- Trade Name
- Smaha Forcep Needle Holder Curved EUDAMED
- Device Name
- Smaha Forcep Needle Holder Curved EUDAMED
- Model / Reference
- PP 554-1025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G494PP55410250 EUDAMED
- Basic UDI-DI
- ++G494PP5541025NE EUDAMED
- EMDN Code
- L0205 NEEDLE HOLDERS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Smaha Forcep Needle Holder Curved by Ameda Instruments Company — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | ++G494PP5541025NE | Class I | Active |
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Manufacturer
- Manufacturer
- Ameda Instruments Company
- EUDAMED SRN
- PK-MF-000031628
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED a2c3a727-e50c-4f0e-8dc7-8bacd2e3944a 61 fields · synced Jul 24, 2026