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Opero Set Angiography Set
EUDAMEDClass I (EU MDR)
Ref W910020000Model Interventional Surgical Pack Model Interventional Surgical Pack
Identity
- Trade Name
- OPERO SET ANGIOGRAPHY SET EUDAMEDAngiography set EUDAMED
- Device Name
- Interventional Surgical Pack EUDAMEDAngiography set EUDAMED
- Model / Reference
- Interventional Surgical Pack EUDAMEDW910020000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288671118 EUDAMED
- Basic UDI-DI
- 69562886LA0001KV EUDAMEDB-06956288671118 EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France EUDAMEDPoland 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
Opero Set Angiography Set 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 | 69562886LA0001KV | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69562886LA0001KV | 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 d72f8a19-d800-4241-a562-004eb1faccb0 61 fields · synced Jul 28, 2026
- EUDAMED 97a7a771-b77a-45db-949f-fe57edda0c33 61 fields · synced May 16, 2026