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Vertical isolation set sterile
EUDAMEDClass I (EU MDR)
Ref TRO070-07Model Orthopedic Surgical Pack
Identity
- Trade Name
- Vertical isolation set sterile EUDAMEDVertical isolation set EUDAMED
- Device Name
- Orthopedic Surgical Pack EUDAMEDVertical isolation set EUDAMED
- Model / Reference
- Orthopedic Surgical Pack EUDAMEDTRO070-07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288667340 EUDAMED
- Basic UDI-DI
- 69562886JA0001K3 EUDAMEDB-06956288667340 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
Vertical isolation set 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 | 69562886JA0001K3 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69562886JA0001K3 | 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 e9364851-1aa2-497d-a2d5-057e6c319a90 61 fields · synced Jul 23, 2026
- EUDAMED 9278668a-0438-4222-a5da-d69d419f52bb 61 fields · synced May 18, 2026