Identity
- Device Name
- Disposable Nitrile Gloves EUDAMED
- Model / Reference
- S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974681690239 EUDAMED
- Basic UDI-DI
- 697468169Nitrile-Glove5V EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Disposable Nitrile Gloves by Shanghai chongjen industry 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 | 697468169Nitrile-Glove5V | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai chongjen industry co., ltd
- EUDAMED SRN
- CN-MF-000009780
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 3ca333c3-d6e6-430e-bf83-ae411777a260 61 fields · synced Jun 18, 2026