Paediatric Mask - Paediatric Mask
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Paediatric Mask; Infant #1; 15 mm O.D. EUDAMEDPaediatric Mask; Infant FDA UDI
- Generic Name
- Anaesthesia face mask, reusable FDA UDI
- Device Name
- Face Masks - Paediatric Mask EUDAMED#1; 15 mm OD. FDA UDI
- Model / Reference
- 88-11-001 EUDAMEDFDA UDI
- Description
- #1; 15 mm OD. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 14250105630531 EUDAMEDFDA UDI
- Basic UDI-DI
- 42501056-1.5.7-W5 EUDAMED
- FDA Product Code
- BYW FDA UDI
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
- GMDN Term
- Anaesthesia face mask, reusable FDA UDI
- Models / Variants
- Paediatric Mask FDA UDIEUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5675 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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
Yes
Category: Anaesthesia face mask, reusable
Paediatric Mask - Paediatric Mask by VBM Medizintechnik GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 2 models — regulatory data on deviCERTS
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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
- VBM Medizintechnik GmbH
Sources (2)
- FDA UDI 7feca470-a775-40fc-89e0-c2d363257411 36 fields · synced Jul 22, 2026
- EUDAMED 80aec943-58f9-46a2-97a0-4e52aa32ac24 61 fields · synced Jul 22, 2026