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Hot Cold Pack (Cold Sleeve)

EUDAMED

Class I (EU MDR)

Ref FM-461Ref FM-463KRef FM-462Ref FM-462KRef FM-467

by FIRSTAR HEALTHCARE COMPANY LlMITED(GUANGZHOU)

Identity

Trade Name
Hot Cold Pack (Cold Sleeve) EUDAMED
Device Name
Hot Cold Pack (Cold Sleeve) EUDAMED
Model / Reference
FM-461 EUDAMED
FM-463K EUDAMED
FM-462 EUDAMED
FM-462K EUDAMED
FM-467 EUDAMED

Identifiers

Primary DI / UDI-DI
06942272646101 EUDAMED
06942272654632 EUDAMED
06942272646200 EUDAMED
06942272654625 EUDAMED
06942272646705 EUDAMED
Basic UDI-DI
69422726P4.09.01Z5 EUDAMED
EMDN Code
Z120602 PHYSIOTHERAPY EQUIPMENT EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Finland 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

Hot Cold Pack (Cold Sleeve) by FIRSTAR HEALTHCARE COMPANY LlMITED(GUANGZHOU) — 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
FIRSTAR HEALTHCARE COMPANY LlMITED(GUANGZHOU)
EUDAMED SRN
CN-MF-000009645
Authorised Representative
MedPath GmbH DE-AR-000000087

Sources (5)

  • EUDAMED 05ab0dd9-98dc-44c7-a5dd-2fad06c648d4 61 fields · synced Oct 6, 2026
  • EUDAMED 4de7a323-e2c0-43dd-aa47-5196f2766c5e 61 fields · synced May 16, 2026
  • EUDAMED 7c576cff-9437-4d10-892d-b8e9f16b6ca8 61 fields · synced May 17, 2026
  • EUDAMED d6bbdbc7-04e3-4808-8fbe-7691a92385db 61 fields · synced May 18, 2026
  • EUDAMED 6e1a3288-d15f-4455-b011-3c79a9146ae7 61 fields · synced May 18, 2026