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Headgear
EUDAMEDClass I (EU MDR)
Ref ESH0101002Model CP611001、CP611002Ref ESH0101001
Identity
- Trade Name
- Headgear EUDAMED
- Device Name
- Headgear EUDAMED
- Model / Reference
- CP611001、CP611002 EUDAMEDESH0101002 EUDAMEDESH0101001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946430414236 EUDAMED06946430414229 EUDAMED
- Basic UDI-DI
- 694643043889515UF EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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: Pulmonary function analysis system, adult
Headgear by Xiamen Compower Medical Tech. Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 694643043889515UF | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Compower Medical Tech. Co., Ltd.
- EUDAMED SRN
- CN-MF-000011703
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (2)
- EUDAMED 621ca405-3065-4348-9ec4-a6963cd7eca5 61 fields · synced Jul 18, 2026
- EUDAMED 001a9a5b-05c3-4cbb-932d-e838cbf4d038 61 fields · synced May 17, 2026