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En-Ka
EUDAMEDClass IIa (EU MDR)
Ref AS-35HModel AS-35A, AS-35E, AS-35I, AS-35K, AS-35H, AS-35X, AS-35W, BA6310, BA4900, BA4110
Identity
- Trade Name
- EN-KA 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 EUDAMEDAS-35H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947707703930 EUDAMED
- Basic UDI-DI
- 6947707706016CS EUDAMED
- Direct Marketing DI
- 06947707703930 EUDAMED
- EMDN Code
- Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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
En-Ka 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 a7fe0dd6-895a-45da-b217-a32fc4a0cc1e 61 fields · synced Jul 13, 2026