Identity
- Trade Name
- BUCKLE 1X 3/8 N.P.S EUDAMED
- Device Name
- Body-powered hand prosthesis EUDAMED
- Model / Reference
- NFT0080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50563495081220 EUDAMED
- Basic UDI-DI
- 50553482MEH0008P EUDAMED
- EMDN Code
- Y061899 UPPER EXTREMITY PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Buckle 1x 3/8 N.p.s by Hugh Steeper Limited — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 50553482MEH0008P | Class I | Active |
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Manufacturer
- Manufacturer
- Hugh Steeper Limited
- EUDAMED SRN
- GB-MF-000010196
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED d06705d8-75a9-4a96-94f2-ad59545b63ec 61 fields · synced Jun 19, 2026