Identity
- Trade Name
- RTU Pack sterile EUDAMEDRTU Pack EUDAMED
- Device Name
- General Surgical Pack EUDAMEDRTU Pack EUDAMED
- Model / Reference
- General Surgical Pack EUDAMED64002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956288673464 EUDAMED
- Basic UDI-DI
- 69562886MA0002LC EUDAMEDB-06956288673464 EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
RTU 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 | 69562886MA0002LC | Class I | Active |
| EUDAMED | European Union | CE/MDR | 69562886MA0002LC | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cobes Industries(Hefei) Co., Ltd
- EUDAMED SRN
- CN-MF-000012364
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 10b83470-1d59-41a8-b83e-a3ccbce78afe 61 fields · synced Jun 18, 2026
- EUDAMED 32f9c453-0613-4dba-bf97-9bb15dc9deb7 61 fields · synced May 18, 2026