Identity
- Trade Name
- Biogel Dental EUDAMED
- Device Name
- Biogel NRL Non Sterile Gloves EUDAMED
- Model / Reference
- 5642 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055186414351 EUDAMED
- Basic UDI-DI
- 733243000000000068KA EUDAMED
- EMDN Code
- T010201 LATEX EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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
Biogel Dental by Mölnlycke Health Care AB — 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 | 733243000000000068KA | Class I | Active |
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Manufacturer
- Manufacturer
- Mölnlycke Health Care AB
- EUDAMED SRN
- SE-MF-000014042
Sources (1)
- EUDAMED 37886f0f-8090-4c5d-963f-88ac17f5284b 61 fields · synced Oct 7, 2026