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Heldenwerk GmbH

EUDAMED

Class I (EU MDR)

Ref KK-PR-B700Ref KK-PR-B140Ref KK-RP-B400Ref KK-PR-B150Ref KK-PR-B260

by Koolcare Technology Co., Ltd.

Identity

Trade Name
Heldenwerk GmbH EUDAMED
Device Name
Cold/Hot Pack EUDAMED
Model / Reference
KK-PR-B700 EUDAMED
KK-PR-B140 EUDAMED
KK-RP-B400 EUDAMED
KK-PR-B150 EUDAMED
KK-PR-B260 EUDAMED

Identifiers

Primary DI / UDI-DI
06974423590476 EUDAMED
06974423590384 EUDAMED
06974423590445 EUDAMED
06974423590353 EUDAMED
06974423590391 EUDAMED
Basic UDI-DI
697442359RPAUM EUDAMED
EMDN Code
Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Germany 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

Heldenwerk GmbH by Koolcare Technology 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
Koolcare Technology Co., Ltd.
EUDAMED SRN
CN-MF-000017687
Authorised Representative
Prolinx GmbH DE-AR-000005129

Sources (5)

  • EUDAMED 261843b7-d295-433e-a34b-5956ab18a502 61 fields · synced Jul 15, 2026
  • EUDAMED 7b37fe59-ef3f-4f0b-bba8-832bea3df0c9 61 fields · synced May 18, 2026
  • EUDAMED db0826c2-d60b-464d-9c92-341d00e605ba 61 fields · synced May 18, 2026
  • EUDAMED 424916ac-53bc-49fa-a389-35c4cc0ef95f 61 fields · synced May 19, 2026
  • EUDAMED dfbe57f5-047a-46aa-9b29-c3829b008b61 61 fields · synced May 19, 2026