Identity
- Trade Name
- Nitril Plus 300S EUDAMED
- Device Name
- Sterile Nitrile Examination Gloves EUDAMED
- Model / Reference
- XS, S, M, L, XL EUDAMEDNESP1003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973951581345 EUDAMED
- Basic UDI-DI
- 697395158NEUS100XKA EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES 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
Nitril Plus 300S by Grand Work Plastic Products 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 | 697395158NEUS100XKA | Class I | Active |
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Manufacturer
- Manufacturer
- Grand Work Plastic Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000023986
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 776c25f1-355e-4b27-ab6f-a6238e8d0cdf 61 fields · synced Jun 19, 2026