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General Orthopedic Pack
EUDAMEDClass I (EU MDR)
Ref N76A05-OS15IA-B08Model N76A05 N76A05-00 N76A05-01 N76A05-02 N76A05-03 O76A05
Identity
- Device Name
- General Orthopedic Pack EUDAMED
- Model / Reference
- N76A05 N76A05-00 N76A05-01 N76A05-02 N76A05-03 O76A05 EUDAMEDN76A05-OS15IA-B08 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975197845908 EUDAMED
- Basic UDI-DI
- 697519784Z59X8 EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
General Orthopedic Pack by Leboo (Hubei) Healthcare Products 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 | 697519784Z59X8 | Class I | Active |
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Manufacturer
- Manufacturer
- Leboo (Hubei) Healthcare Products Limited
- EUDAMED SRN
- CN-MF-000021186
- Authorised Representative
- Share info GmbH DE-AR-000005132
Sources (1)
- EUDAMED 7490448e-565b-4b5f-8676-7eb056e5f684 61 fields · synced Jun 18, 2026