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Craniotomy Pack
EUDAMEDClass I (EU MDR)
Ref N76G01-OS15IA-B00Model N76G01 O76G01 N76G01-00 N76G01-01 N76G01-02 N76G01-03
Identity
- Device Name
- Craniotomy Pack EUDAMED
- Model / Reference
- N76G01 O76G01 N76G01-00 N76G01-01 N76G01-02 N76G01-03 EUDAMEDN76G01-OS15IA-B00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975197846509 EUDAMED
- Basic UDI-DI
- 697519784Z65X3 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
Craniotomy 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 | 697519784Z65X3 | 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 848a200d-255c-4d5d-9de3-eb51135a14af 61 fields · synced Oct 6, 2026