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Craniotomy pack
EUDAMEDClass I (EU MDR)
Ref 62004Model Neurosurgery Surgical Pack
Identity
- Trade Name
- Craniotomy pack EUDAMEDCraniotomy pack sterile EUDAMED
- Device Name
- Craniotomy pack sterile EUDAMEDNeurosurgery Surgical Pack EUDAMED
- Model / Reference
- Neurosurgery Surgical Pack EUDAMED62004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288673679 EUDAMED
- Basic UDI-DI
- B-06956288673679 EUDAMED69562886FA0001HF EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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 Cobes Industries(Hefei) Co., Ltd — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06956288673679 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06956288673679 | Class I | Active |
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Manufacturer
- Manufacturer
- Cobes Industries(Hefei) Co., Ltd
- EUDAMED SRN
- CN-MF-000012364
- Authorised Representative
- DISPOMED S.A.S FR-AR-000000891
Sources (2)
- EUDAMED e209f35b-de04-4cc5-a8b4-20d906762670 61 fields · synced Jul 13, 2026
- EUDAMED 9a913bab-23e6-41d3-a6d0-63166e4bf931 61 fields · synced May 18, 2026