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Dr.Hegeli

EUDAMED

Class IIa (EU MDR)

Ref BA4900Model AS-35A, AS-35E, AS-35I, AS-35K, AS-35H, AS-35X, AS-35W, BA6310, BA4900, BA4110

by Xiamen Ants-Bro Technology Co., Ltd.

Identity

Trade Name
Dr.Hegeli 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 EUDAMED
BA4900 EUDAMED

Identifiers

Primary DI / UDI-DI
06947707703909 EUDAMED
Basic UDI-DI
6947707706016CS EUDAMED
Direct Marketing DI
06947707703909 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

Dr.Hegeli 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

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Manufacturer

EUDAMED SRN
CN-MF-000010562
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (1)

  • EUDAMED 9e106f51-3d03-4445-b2e2-a30670530566 61 fields · synced Jun 19, 2026