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Opero Set Universal Set With "u" Drape
EUDAMEDClass I (EU MDR)
Ref W913000000Model General Surgical Pack
Identity
- Trade Name
- OPERO SET UNIVERSAL SET WITH "U" DRAPE EUDAMEDUniversal set with "u" drape EUDAMED
- Device Name
- General Surgical Pack EUDAMEDUniversal set with "u" drape EUDAMED
- Model / Reference
- General Surgical Pack EUDAMEDW913000000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288660211 EUDAMED
- Basic UDI-DI
- 69562886MA0004LG EUDAMEDB-06956288660211 EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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 Universal Set With "u" Drape 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 | 69562886MA0004LG | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69562886MA0004LG | 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 28f8ee44-ff24-474f-b082-ea51eb9d9662 61 fields · synced Oct 7, 2026
- EUDAMED c755b6d5-2af3-4b71-bccc-529bb1debc49 61 fields · synced May 19, 2026