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Digital Thermometer

EUDAMED

Class IIa (EU MDR)

Ref PT-111H Model PT-01A,PT-01B,PT-01C,PT-01D,PT-01E,PT-01F,PT-01H,PT-11A,PT-11B,PT-11C,PT-11D,PT-11E,PT-11F,PT-101A.PT-101B,PT-101C,PT-101D，PT-101E,PT-101H,PT-111A,PT-111B,PT-111H,PT-02A,PT-02B,PT-02C,PT-02D,PT-02E,PT-02F,PT-12A,PT-12C,PT-102H,PT-112B

by Hangzhou Ouhui Technology Co., Ltd.

Identity

Trade Name
Digital Thermometer EUDAMED
Device Name
Digital Thermometer EUDAMED
Model / Reference
PT-01A,PT-01B,PT-01C,PT-01D,PT-01E,PT-01F,PT-01H,PT-11A,PT-11B,PT-11C,PT-11D,PT-11E,PT-11F,PT-101A.PT-101B,PT-101C,PT-101D，PT-101E,PT-101H,PT-111A,PT-111B,PT-111H,PT-02A,PT-02B,PT-02C,PT-02D,PT-02E,PT-02F,PT-12A,PT-12C,PT-102H,PT-112B EUDAMED
PT-111H EUDAMED

Identifiers

Primary DI / UDI-DI
06973167540273 EUDAMED
Basic UDI-DI
697316754PT001KA 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

Digital Thermometer by Hangzhou Ouhui 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

Manufacturer
Hangzhou Ouhui Technology Co., Ltd.
EUDAMED SRN
CN-MF-000030483
Authorised Representative
Luxus Lebenswelt GmbH DE-AR-000005110

Sources (1)

  • EUDAMED 93d581d3-a932-47f5-a37a-e1db008802a6 61 fields · synced Jul 25, 2026