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Perfit Ace
EUDAMEDClass I (EU MDR)
Ref ECC0102004Model COL004、COL005、COL006、COL007
Identity
- Trade Name
- Perfit Ace EUDAMED
- Device Name
- Collar EUDAMED
- Model / Reference
- COL004、COL005、COL006、COL007 EUDAMEDECC0102004 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06946430426291 EUDAMED
- Basic UDI-DI
- 694643041093801PA EUDAMED
- EMDN Code
- M0399 BANDAGES - OTHER (see Y06 for collars, tutors, etc.) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Perfit Ace by Xiamen Compower Medical Tech. Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 694643041093801PA | 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 (1)
- EUDAMED 6c974484-665e-4e97-b2b7-70703b32f1fc 61 fields · synced Jun 18, 2026