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ClearFlex™ plus Silicone anaesthetic face mask paediatric +1 more model
EUDAMEDClass IIa (EU MDR)
Ref 8749222
Identity
- Trade Name
- ClearFlex™ plus Silicone anaesthetic face mask paediatric; 22 mm I.D. EUDAMED
- Device Name
- Face Masks - Bi-Mask EUDAMED
- Model / Reference
- 8749222 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 14250105630791 EUDAMED
- Basic UDI-DI
- 42501056-1.5.3-VR EUDAMED
- Direct Marketing DI
- 04250105630794 EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
- Models / Variants
- 22 mm I.D. 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
ClearFlex™ plus Silicone anaesthetic face mask paediatric +1 more model by VBM Medizintechnik GmbH — Class IIa — MDR — listed in EUDAMED — 2 models
Similar devices
Also classified as Anaesthesia face mask, single-use.
- Ventlab — Ventlab Corp. · Class I
- Resp-O2 Air Cushion Mask with Valve, Size #1, Neonate/Infant — Dynarex Corp. · Class I
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- Vital Signs™ — Airlife, Inc. · Class I
- Ventlab — Ventlab Corp. · Class I
- Anesthesia mask — Henan Tuoren Medical Device Co., Ltd · Class IIa
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- King Mask — Ambu A/S · Class I
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 | 42501056-1.5.3-VR | Class IIa | Active |
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Manufacturer
- Manufacturer
- VBM Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000005907
Sources (1)
- EUDAMED f192a788-e5c4-45f6-b5f3-2ccea58d05b4 61 fields · synced Aug 1, 2026