Identity
- Trade Name
- Biogel Super-Sensitive EUDAMED
- Device Name
- Biogel NRL Sterile Surgicals Gloves EUDAMED
- Model / Reference
- 97580 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060097932658 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 Super-Sensitive 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 535a93a3-206e-4f3d-b7ae-014e84a78dc8 61 fields · synced Oct 7, 2026