Identity
- Trade Name
- LiMAx Breathing Mask Set B EUDAMED
- Device Name
- LiMAx Breathing Mask EUDAMED
- Model / Reference
- 201002MR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120087610099 EUDAMED
- Basic UDI-DI
- 912008761HUM100088 EUDAMED
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
LiMAx Breathing Mask Set B by Humedics GmbH — 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 | 912008761HUM100088 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Humedics GmbH
- EUDAMED SRN
- DE-MF-000005094
Sources (1)
- EUDAMED 386c5b30-b20a-4421-ab2a-3c8aa23e1b85 61 fields · synced Jun 17, 2026