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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 S EUDAMEDPristine ARsoft ® Powder Free Nitrile Examination Gloves, Accelerator-free, Indigo Blue, size XS EUDAMEDPristine ARsoft ® Powder Free Nitrile Examination Gloves, Accelerator-free, Indigo Blue, size XXL EUDAMEDPristine ARsoft ® Powder Free Nitrile Examination Gloves, Accelerator-free, Indigo Blue, size XL EUDAMED
- Device Name
- Powder Free Nitrile Examination Gloves EUDAMED
- Model / Reference
- NGPF EUDAMEDNGPF-45I EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555867104794 EUDAMED09555867104787 EUDAMED09555867104831 EUDAMED09555867104824 EUDAMED
- Basic UDI-DI
- 955586710NGPFR8 EUDAMED
- Unit of Use DI
- 29555867104798 EUDAMED29555867104781 EUDAMED29555867104835 EUDAMED29555867104828 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 (4)
- EUDAMED 0afc35a0-53a6-4378-a77a-b5529ab9ff69 61 fields · synced Oct 6, 2026
- EUDAMED dbc6e276-ccf9-4edf-982e-592e753bd96b 61 fields · synced May 17, 2026
- EUDAMED 4e3b6527-39ae-42ea-b777-4136fd4a914d 61 fields · synced May 17, 2026
- EUDAMED bce01136-14e6-4bf8-8130-a94ebbde758d 61 fields · synced May 19, 2026