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Green Softbag

EUDAMED

Class IIa (EU MDR)

Ref F2128Model B001

by RFX+CARE Manufacturing Co., Ltd.

Identity

Trade Name
Green Softbag EUDAMED
Device Name
First Aid Kit(B) EUDAMED
Model / Reference
B001 EUDAMED
F2128 EUDAMED

Identifiers

Primary DI / UDI-DI
05706636584499 EUDAMED
Basic UDI-DI
B-05706636584499 EUDAMED
EMDN Code
V0501 CLINICAL EMERGENCY KITS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Denmark EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Green Softbag by RFX+CARE Manufacturing Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

EUDAMED SRN
CN-MF-000002971
Authorised Representative
RFX+Care International A/S DK-AR-000001768

Sources (1)

  • EUDAMED 7479274d-29f9-4974-a82f-c4ee66eecc32 61 fields · synced Jun 20, 2026