Endoscopy Mask - Endoscopy Mask
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Endoscopy Mask; medium Ø 3 mm; tubing: 15 mm O.D.; 155 mm EUDAMEDEndoscopy Mask; medium FDA UDI
- Generic Name
- Anaesthesia face mask, single-use FDA UDI
- Device Name
- Face Masks - Endoscopy Mask EUDAMEDØ 3 mm; tubing: 15 mm O.D.; 155 mm FDA UDI
- Model / Reference
- 30-40-333 EUDAMEDFDA UDI
- Description
- Ø 3 mm; tubing: 15 mm O.D.; 155 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250105629767 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 FDA UDIEUDAMED
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
Yes
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
No
Category: Anaesthesia face mask, single-use
Endoscopy Mask - Endoscopy Mask by VBM Medizintechnik GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 2 models — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, single-use.
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- King Mask — Ambu A/S · Class I
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
- VBM Medizintechnik GmbH
Sources (2)
- FDA UDI 5c14b40d-3627-4ba4-b33d-887b57ed5c81 36 fields · synced Jul 26, 2026
- EUDAMED 9a7983d6-9bba-4f4b-99e6-6c509b1d118d 61 fields · synced Jul 26, 2026