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everchek
EUDAMEDClass IIa (EU MDR)
Ref CN10Model AS-35A, AS-35E, AS-35I, AS-35K, AS-35H, AS-35X, AS-35W, BA6310, BA4900, BA4110
Identity
- Trade Name
- everchek EUDAMED
- Device Name
- Automated non-invasive Sphygmomanometer EUDAMED
- Model / Reference
- AS-35A, AS-35E, AS-35I, AS-35K, AS-35H, AS-35X, AS-35W, BA6310, BA4900, BA4110 EUDAMEDCN10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05907814464552 EUDAMED
- Basic UDI-DI
- 6947707706016CS EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
everchek by Xiamen Ants-Bro Technology Co., Ltd. — Class IIa — 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 | 6947707706016CS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Xiamen Ants-Bro Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010562
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 5cbe756c-e2f5-4763-b5fd-bb9556769f61 61 fields · synced Jun 18, 2026