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Howell

EUDAMED

Class I (EU MDR)

Ref HE-02-1-BModel HE-04T-8, HE-05,HE-05-2, HE-04T-11, HE-04T-3, HE-04T-4, HE-04-A-2, HE-04T-1, HE-04-5, HE-04T-2, HE-T7-3-1, HE-04-11, HE-02-1-1-B, HE-02-1-1-A, HE-02-14, HE-05T-3, HE-07-8-1, HE-05T-6, HE-07-7-1, HE-02-T, HE-04T-9，HE-07-C,HE-05-5, HE-08-1,etc.

by Harbin Howell Medical Apparatus and Instruments Co., Ltd.

Identity

Trade Name
Howell EUDAMED
Device Name
Polymer Gel Pads EUDAMED
Model / Reference
HE-04T-8, HE-05,HE-05-2, HE-04T-11, HE-04T-3, HE-04T-4, HE-04-A-2, HE-04T-1, HE-04-5, HE-04T-2, HE-T7-3-1, HE-04-11, HE-02-1-1-B, HE-02-1-1-A, HE-02-14, HE-05T-3, HE-07-8-1, HE-05T-6, HE-07-7-1, HE-02-T, HE-04T-9，HE-07-C,HE-05-5, HE-08-1,etc. EUDAMED
HE-02-1-B EUDAMED

Identifiers

Primary DI / UDI-DI
06974445422359 EUDAMED
Basic UDI-DI
697444542HETWD02-2P4 EUDAMED
EMDN Code
V080302 PATIENT POSITIONING MEDICAL CUSHIONS EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Greece EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

Yes

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

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Howell by Harbin Howell Medical Apparatus and Instruments Co., Ltd. — Class I — 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
Harbin Howell Medical Apparatus and Instruments Co., Ltd.
EUDAMED SRN
CN-MF-000025141
Authorised Representative
Caretechion GmbH DE-AR-000005946

Sources (1)

  • EUDAMED 985f7c11-3e4e-44a6-9064-c072656ff55c 61 fields · synced Jun 18, 2026