Identity
- Trade Name
- gloves EUDAMED
- Device Name
- Examination Gloves EUDAMED
- Model / Reference
- SH-8130 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974567461250 EUDAMED06974567460406 EUDAMED
- Basic UDI-DI
- 6974567460000666 EUDAMED
- Direct Marketing DI
- 06974567461250 EUDAMED06974567460406 EUDAMED
- EMDN Code
- T01020201 VINYL EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMEDGermany 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
gloves 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 (2)
- EUDAMED 329a6a8b-5aef-48d7-b0cb-7fa98b2c2ad0 61 fields · synced Oct 6, 2026
- EUDAMED 664cd2d3-d461-431d-956b-d9bc4905ebbc 61 fields · synced May 17, 2026