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Comfort Plus
EUDAMEDClass IIa (EU MDR)
Ref BA4110Model AS-35A, AS-35E, AS-35I, AS-35K, AS-35H, AS-35X, AS-35W, BA6310, BA4900, BA4110Ref AS-35E
Identity
- Trade Name
- COMFORT PLUS 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 EUDAMEDBA4110 EUDAMEDAS-35E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947707703800 EUDAMED06947707703817 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
- 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
Comfort Plus 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 (2)
- EUDAMED df7c9bf2-e657-4cc3-8e79-cb44aa116975 61 fields · synced Jul 10, 2026
- EUDAMED 2eaf36e6-4ae8-4491-9c07-ab2baca4a528 61 fields · synced May 16, 2026