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ph Handsafe
EUDAMEDClass I (EU MDR)
Ref GN90 Extra LargeModel Nitrile Powder Free Examination GloveRef GN65 SmallModel Vinyl Powder Free Examination GloveRef GN65 Medium
Identity
- Trade Name
- ph Handsafe EUDAMED
- Device Name
- ph Handsafe Nitrile Powder Free Examination Glove EUDAMEDHandSafe Clear Vinyl Powder Free Examination Glove EUDAMED
- Model / Reference
- Nitrile Powder Free Examination Glove EUDAMEDGN90 Extra Large EUDAMEDVinyl Powder Free Examination Glove EUDAMEDGN65 Small EUDAMEDGN65 Medium EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05024951012757 EUDAMED05024951023746 EUDAMED05024951023753 EUDAMED
- Basic UDI-DI
- 5024951GNPFNS00YA EUDAMED5024951GVPFNS004M EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMEDT01020201 VINYL EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDEUDAMED
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
ph Handsafe by Polyco Healthline Group Limited — 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 | 5024951GNPFNS00YA | Class I | Active |
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Manufacturer
- Manufacturer
- Polyco Healthline Group Limited
- EUDAMED SRN
- GB-MF-000015289
- Authorised Representative
- International Associates Auditing & Certification Limited IE-AR-000002248
Sources (4)
- EUDAMED e09f877b-f1bf-4bb2-95d6-5bb5876df2c1 61 fields · synced Aug 3, 2026
- EUDAMED 7ceaf4c7-a57a-4214-bedb-bfc6c66e88e9 61 fields · synced May 18, 2026
- EUDAMED fbc9d06a-ee01-42e0-acef-286b72c371dd 61 fields · synced Jul 10, 2026
- EUDAMED 0ef2387e-5bb1-47a5-af38-a962e7918940 61 fields · synced Aug 3, 2026