Identity
- Trade Name
- Endoscopy Mask; small Ø 2 mm; tubing: 15 mm O.D.; 155 mm EUDAMEDEndoscopy Mask; small FDA UDI
- Generic Name
- Anaesthesia face mask, single-use FDA UDI
- Device Name
- Face Masks - Endoscopy Mask EUDAMEDØ 2 mm; tubing: 15 mm O.D.; 155 mm FDA UDI
- Model / Reference
- 30-40-111 EUDAMEDFDA UDI
- Description
- Ø 2 mm; tubing: 15 mm O.D.; 155 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250105629750 EUDAMEDFDA UDI
- Basic UDI-DI
- 42501056-1.5.2-VN EUDAMED
- FDA Product Code
- BSJ FDA UDI
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
- GMDN Term
- Anaesthesia face mask, single-use FDA UDI
- Models / Variants
- Endoscopy Mask EUDAMEDFDA 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Anaesthesia face mask, single-use
Endoscopy Mask - Endoscopy Mask by VBM Medizintechnik GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — 4 models — regulatory data on deviCERTS
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Also classified as Anaesthesia face mask, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42501056-1.5.2-VN | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- VBM Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000005907
Sources (2)
- EUDAMED 0de68adf-8ebe-4955-8247-b0eb82720f36 61 fields · synced Oct 7, 2026
- FDA UDI 56657ee5-e8c2-47ba-94e4-e0a04232efca 36 fields · synced May 30, 2026