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Limb surgery kit sterile
EUDAMEDClass I (EU MDR)
Ref SC85044Model Orthopedic Surgical Pack
Identity
- Trade Name
- Limb surgery kit sterile EUDAMEDOrthopedic Surgical Pack EUDAMED
- Device Name
- Orthopedic Surgical Pack EUDAMEDLimb surgery kit EUDAMED
- Model / Reference
- Orthopedic Surgical Pack EUDAMEDSC85044 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288685047 EUDAMED
- Basic UDI-DI
- 69562886JA0003K7 EUDAMEDB-06956288685047 EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Limb surgery kit sterile by Cobes Industries(Hefei) Co., Ltd — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 69562886JA0003K7 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69562886JA0003K7 | Class I | Active |
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Manufacturer
- Manufacturer
- Cobes Industries(Hefei) Co., Ltd
- EUDAMED SRN
- CN-MF-000012364
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 571c65dc-491d-47db-9c85-22df569ed3b1 61 fields · synced Jul 15, 2026
- EUDAMED 8b8f21c7-4b07-4b21-8e91-0277d4bf3228 61 fields · synced May 18, 2026