Identity
- Trade Name
- Headgear EUDAMEDCompower FDA UDI
- Generic Name
- Anaesthesia mask strap, single-use FDA UDI
- Device Name
- Headgear EUDAMEDHeadgear is designed to fit the mask over the patient's head. FDA UDI
- Model / Reference
- CP611001、CP611002 EUDAMEDESH0101001 EUDAMEDCP611001 FDA UDI
- Description
- Headgear is designed to fit the mask over the patient's head. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06946430423320 EUDAMEDFDA UDI
- Basic UDI-DI
- 694643043889515UF EUDAMED
- FDA Product Code
- BTK FDA UDI
- EMDN Code
- R9080 RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Anaesthesia mask strap, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5560 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
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
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Gas-sampling/monitoring respiratory tubing, single-use
Headgear by Xiamen Compower Medical Tech. Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 694643043889515UF | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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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 90c12cd8-6aef-4775-825a-50d43f055d3d 61 fields · synced Sep 18, 2026
- FDA UDI 59f91451-b802-49d3-a98d-29a2be60ec51 33 fields · synced May 30, 2026