Identity
- Device Name
- Latex Examination Gloves (Latex Powdered) EUDAMED
- Model / Reference
- LPP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09555954300092 EUDAMED09555954300108 EUDAMED
- Basic UDI-DI
- 955595430LPPVF EUDAMED
- Direct Marketing DI
- 09555954300092 EUDAMED09555954300108 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 (2)
- EUDAMED c8ef4cfa-932b-44fc-91ae-93b00ce96a14 61 fields · synced Jul 29, 2026
- EUDAMED f677e8bd-108d-4fc1-ae79-525e87c48c0e 61 fields · synced May 17, 2026