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Inhalation Antalgic Equipment（Sedation system)
EUDAMEDClass IIa (EU MDR)
Ref AII5000E
Identity
- Trade Name
- Inhalation Antalgic Equipment（Sedation system) EUDAMED
- Device Name
- Inhalation Antalgic Equipment（Sedation system) EUDAMED
- Model / Reference
- AII5000E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970658140530 EUDAMED
- Basic UDI-DI
- B-06970658140530 EUDAMED
- EMDN Code
- R060203 INHALATION THERAPY HUMIDIFICATION LIQUIDS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Inhalation Antalgic Equipment（Sedation system) by Ambulanc(Shenzhen)Tech.Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06970658140530 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ambulanc(Shenzhen)Tech.Co., Ltd.
- EUDAMED SRN
- CN-MF-000010435
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED ecd0b9ae-efa8-4ac7-9793-01c4323afb94 61 fields · synced Jul 9, 2026