Identity
- Device Name
- Column Drape EUDAMED
- Model / Reference
- M005 EUDAMEDNone EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972948701152 EUDAMED
- Basic UDI-DI
- 697294870CD1000CC EUDAMED
- EMDN Code
- T030201 MECHANICAL ARMS COVERS 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
Column Drape by Suzhou Kangduo Robot Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697294870CD1000CC | Class I | Active |
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Manufacturer
- Manufacturer
- Suzhou Kangduo Robot Co., Ltd.
- EUDAMED SRN
- CN-MF-000033401
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED 340243a0-ce6c-4ac2-b020-f9add4cd6b81 61 fields · synced Jul 12, 2026