Identity
- Trade Name
- Biogel PI Micro MyFit EUDAMED
- Device Name
- Biogel Synthetic Sterile Surgical Gloves EUDAMED
- Model / Reference
- 6648570 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333350811372 EUDAMED
- Basic UDI-DI
- 733243000000000072JZ EUDAMED
- EMDN Code
- T01010203 POLYISOPREN 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
No
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 PI Micro MyFit 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 | 733243000000000072JZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mölnlycke Health Care AB
- EUDAMED SRN
- SE-MF-000014042
Sources (1)
- EUDAMED b595ad55-4e64-48dd-9230-a250c119cda8 61 fields · synced Oct 8, 2026