Identity
- Device Name
- Instrument Arm Drape EUDAMED
- Model / Reference
- M003 EUDAMEDNone EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972948701138 EUDAMED26972948701135 EUDAMED36972948701132 EUDAMED
- Basic UDI-DI
- 697294870IAD1000M6 EUDAMED
- EMDN Code
- T030201 MECHANICAL ARMS COVERS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Instrument Arm 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 | 697294870IAD1000M6 | 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 (3)
- EUDAMED 7df48f65-8149-4f23-8696-17c21d3aaf9e 61 fields · synced Jul 16, 2026
- EUDAMED 03cb3b60-a4d5-4815-9b3e-7700797b409e 61 fields · synced May 17, 2026
- EUDAMED 7ebb8ce4-fffc-4764-9746-398004c23f6f 61 fields · synced May 17, 2026