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Universal Drape Pack
EUDAMEDClass I (EU MDR)
Ref SC81004IEModel General Surgical PackRef 047266RSModel Scrub Suit
Identity
- Trade Name
- Universal Drape Pack EUDAMEDType A Scrub Suit Size S - Red EUDAMED
- Device Name
- Universal Drape Pack EUDAMEDType A Scrub Suit EUDAMED
- Model / Reference
- General Surgical Pack EUDAMEDSC81004IE EUDAMEDScrub Suit EUDAMED047266RS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288681049 EUDAMED
- Basic UDI-DI
- B-06956288681049 EUDAMED69562886EA0001H2 EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMEDT0205 NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMEDFrance EUDAMED
Clinical & Handling
Sterile
No
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 by Cobes Industries(Hefei) Co., Ltd — Class I — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06956288681049 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06956288681049 | 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 4ea8ea03-ca37-42d4-a3c9-07977b43f84c 61 fields · synced Oct 6, 2026
- EUDAMED efecc3ea-f3da-4c43-94fb-caa48c5708a3 61 fields · synced May 19, 2026