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Reusable Anesthesia Mask
EUDAMEDClass IIa (EU MDR)
Ref AAM0504007Model 0-B#,1-B#,2-B#,3-B#, 4-B#, 5-B#, 6-B#
Identity
- Trade Name
- Reusable Anesthesia Mask EUDAMED
- Device Name
- Reusable Anesthesia Mask EUDAMED
- Model / Reference
- 0-B#,1-B#,2-B#,3-B#, 4-B#, 5-B#, 6-B# EUDAMEDAAM0504007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946430420633 EUDAMED
- Basic UDI-DI
- 694643041245304N8 EUDAMED
- Direct Marketing DI
- 06946430420633 EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS 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
Reusable Anesthesia Mask by Xiamen Compower Medical Tech. Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Anaesthesia face mask, single-use.
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- Anesthesia mask — Henan Tuoren Medical Device Co., Ltd · Class IIa
- King Mask — Ambu A/S · Class I
- RUSCH — TELEFLEX INCORPORATED · Class I
- compower — XIAMEN COMPOWER MEDICAL TECH. CO., LTD · 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 | 694643041245304N8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Xiamen Compower Medical Tech. Co., Ltd.
- EUDAMED SRN
- CN-MF-000011703
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 56d14337-5c2f-4615-939f-c081a2f048a1 61 fields · synced Jun 18, 2026