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Universal Drape Pack sterile
EUDAMEDClass I (EU MDR)
Ref SC81005Model General Surgical Pack
Identity
- Trade Name
- Universal Drape Pack sterile EUDAMEDUniversal Drape Pack EUDAMED
- Device Name
- General Surgical Pack EUDAMEDUniversal Drape Pack EUDAMED
- Model / Reference
- General Surgical Pack EUDAMEDSC81005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288681056 EUDAMED
- Basic UDI-DI
- 69562886MA0004LG EUDAMEDB-06956288681056 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
Universal Drape Pack 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 | 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 cc8825dd-f334-4b01-b89b-42e9ea04f4ba 61 fields · synced Oct 7, 2026
- EUDAMED 48a16207-1544-4b90-9dbf-40b6e46063b2 61 fields · synced May 18, 2026