Identity
- Device Name
- Latex Examination Gloves (Latex Powdered) EUDAMED
- Model / Reference
- LPP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555954300115 EUDAMED
- Basic UDI-DI
- 955595430LPPVF EUDAMED
- Direct Marketing DI
- 09555954300115 EUDAMED
- EMDN Code
- T010201 LATEX 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
Yes
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
Latex Examination Gloves (Latex Powdered) by Apex Glove Sdn Bhd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: High Risk Latex Gloves
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 | 955595430LPPVF | Class I | Active |
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Manufacturer
- Manufacturer
- Apex Glove Sdn Bhd
- EUDAMED SRN
- MY-MF-000049917
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED aed4ab2e-f9b8-4b97-9485-637ddfc5e473 61 fields · synced Jun 18, 2026