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Heat Band

EUDAMED

Class IIa (EU MDR)

Ref 394865Model 628541Ref 392302

by Rapid Aid Vietnam Co., Ltd

Identity

Trade Name
HEAT BAND EUDAMED
Device Name
Menstrual Heat Patches EUDAMED
Model / Reference
628541 EUDAMED
394865 EUDAMED
392302 EUDAMED

Identifiers

Primary DI / UDI-DI
00064317394863 EUDAMED
00064317392302 EUDAMED
Basic UDI-DI
64317ravheatwrap75 EUDAMED
EMDN Code
V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Austria EUDAMED
Croatia 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

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Device sterilization/disinfection container, reusable

Heat Band by Rapid Aid Vietnam Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Device sterilization/disinfection container, reusable.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
VN-MF-000033576
Authorised Representative
Lotus NL B.V. NL-AR-000000121

Sources (2)

  • EUDAMED 4865aad7-7451-4daa-b06c-3c55a664ba84 61 fields · synced Jul 22, 2026
  • EUDAMED e83f8de3-76d5-4a27-8acf-8c68791c5316 61 fields · synced May 18, 2026