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ComfortStar Maske Standard 2
EUDAMEDClass IIa (EU MDR)
Ref MP01512Model 208010PK19L010
Identity
- Trade Name
- ComfortStar Maske Standard 2 EUDAMED
- Model / Reference
- 208010PK19L010 EUDAMEDMP01512 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675421344 EUDAMED
- Basic UDI-DI
- 040486751208010PK19L0102N EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS 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
Category: Anaesthesia face mask, single-use
ComfortStar Maske Standard 2 by Drägerwerk AG & Co. KGaA — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Anaesthesia face mask, single-use.
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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 | 040486751208010PK19L0102N | Class IIa | Active |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
- EUDAMED SRN
- DE-MF-000005329
Sources (1)
- EUDAMED 41384636-d5d6-4444-9580-0b5d6b797e05 61 fields · synced Jun 18, 2026