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Opero Set Delivery Set I
EUDAMEDClass I (EU MDR)
Ref W910000005Model Obstetric Surgical Pack
Identity
- Trade Name
- OPERO SET DELIVERY SET I EUDAMEDDelivery set EUDAMED
- Device Name
- Obstetric Surgical Pack EUDAMEDDelivery set EUDAMED
- Model / Reference
- Obstetric Surgical Pack EUDAMEDW910000005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288664165 EUDAMED
- Basic UDI-DI
- 69562886NA0001LP EUDAMEDB-06956288664165 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 Delivery Set I 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 | 69562886NA0001LP | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69562886NA0001LP | 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 a2420d31-8f55-44a1-8a1f-f6a2d5c02e63 61 fields · synced Oct 6, 2026
- EUDAMED 5dc8254c-ce95-47d8-b4d6-c1f969ec0a5f 61 fields · synced May 17, 2026