Identity
- Trade Name
- Biogel Surgeons EUDAMED
- Device Name
- Biogel NRL Sterile Surgicals Gloves EUDAMED
- Model / Reference
- 82255 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060097931163 EUDAMED
- Basic UDI-DI
- 733243000000000071JX EUDAMED
- EMDN Code
- T01010102 NON-POWDERED LATEX SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
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 Surgeons by Mölnlycke Health Care AB — Class IIa — 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 | 733243000000000071JX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mölnlycke Health Care AB
- EUDAMED SRN
- SE-MF-000014042
Sources (1)
- EUDAMED c59b9bad-77b3-4e77-85ad-ef85c5eb0a8d 61 fields · synced Oct 7, 2026