Identity
- Trade Name
- Rokavica EUDAMED
- Device Name
- Examination Gloves EUDAMED
- Model / Reference
- SH-8130 EUDAMED- EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974567463551 EUDAMED
- Basic UDI-DI
- 6974567460000666 EUDAMED
- Direct Marketing DI
- 06974567463551 EUDAMED
- EMDN Code
- T01020201 VINYL EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Slovenia 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
Rokavica by Danyang Sunmed Healthcare Corporation — 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 | 6974567460000666 | Class I | Active |
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Manufacturer
- Manufacturer
- Danyang Sunmed Healthcare Corporation
- EUDAMED SRN
- CN-MF-000013734
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED b2d2eb16-2549-4a95-a656-b1146af50fec 61 fields · synced Jun 18, 2026