Identity
- Trade Name
- Biogel Diagnostic EUDAMED
- Device Name
- Biogel NRL Non Sterile Gloves EUDAMED
- Model / Reference
- 5658 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060097936977 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 Diagnostic 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mölnlycke Health Care AB
- EUDAMED SRN
- SE-MF-000014042
Sources (1)
- EUDAMED 62664b07-47fb-446a-9f71-c7bc0b52cbe0 61 fields · synced Oct 10, 2026