Mask ComfortStar6stand, w.hook
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- ComfortStar Maske Standard 6 EUDAMEDMask ComfortStar6stand,w.hook FDA UDI
- Generic Name
- Anaesthesia face mask, single-use FDA UDI
- Model / Reference
- MP01516 EUDAMEDFDA UDI208010PK19L010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675035640 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486751208010PK19L0102N EUDAMED
- FDA Product Code
- BSJ FDA UDI
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
- GMDN Term
- Anaesthesia face mask, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5550 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Anaesthesia face mask, single-use
Mask ComfortStar6stand, w.hook by Drägerwerk AG & Co. KGaA — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI 782c66b9-56c8-4549-bce6-b7e3795a5081 33 fields · synced Jun 18, 2026
- EUDAMED 7c27f944-19ee-42d6-969d-4a513871759f 61 fields · synced Jun 18, 2026