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Pristine ARsoft ® Powder Free Nitrile Examination Gloves, Accelerator-free, Ind…
EUDAMEDClass I (EU MDR)
Ref NGPF-45IModel NGPF
Identity
- Trade Name
- Pristine ARsoft ® Powder Free Nitrile Examination Gloves, Accelerator-free, Indigo Blue, size M EUDAMED
- Device Name
- Powder Free Nitrile Examination Gloves EUDAMED
- Model / Reference
- NGPF EUDAMEDNGPF-45I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555867104800 EUDAMED
- Basic UDI-DI
- 955586710NGPFR8 EUDAMED
- Unit of Use DI
- 29555867104804 EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Pristine ARsoft ® Powder Free Nitrile Examination Gloves, Accelerator-free, Ind… by Alliance Rubber Products Sdn. Bhd. — Class I — MDR — listed in EUDAMED
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 | 955586710NGPFR8 | Class I | Active |
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Manufacturer
- Manufacturer
- Alliance Rubber Products Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000008415
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 8d2f0fe5-2d3f-4249-b61c-658ba6bef43b 61 fields · synced Jun 18, 2026