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acofar

EUDAMED

Class IIa (EU MDR)

Ref DT119Model DT007, DT008, DT113, DT116, DT117, DT119Ref DT116

by Guangzhou Berrcom Medical Device Co., Ltd.

Identity

Trade Name
acofar EUDAMED
Device Name
Digital Thermometer EUDAMED
Model / Reference
DT007, DT008, DT113, DT116, DT117, DT119 EUDAMED
DT119 EUDAMED
DT116 EUDAMED

Identifiers

Primary DI / UDI-DI
06947656117680 EUDAMED
06947656117673 EUDAMED
Basic UDI-DI
69476561DTXXX4R EUDAMED
Direct Marketing DI
06947656117680 EUDAMED
06947656117673 EUDAMED
EMDN Code
V0301010201 CONTACT DIGITAL THERMOMETERS (INCLUDING PROBES) EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Spain 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

acofar by Guangzhou Berrcom Medical Device 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-000013852
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

  • EUDAMED 73f05663-1f28-4edf-80b5-a8dfe8147a7d 61 fields · synced Jul 30, 2026
  • EUDAMED 18192623-7bdf-4d8a-bb5c-b8d8a80b6eef 61 fields · synced May 18, 2026