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Ultra-Low Temperature Freezer

EUDAMED

Class IIa (EU MDR)

Ref /Model DW-HL398, DW-HL528, DW-HL678, DW-HL778, DW-HL858, DW-HL1008, DW-HL398SA, DW-HL528SA, DW-HL678SA, DW-HL778SA, DW-HL858SA, DW-HL1008SA, DW-HL398S, DW-HL528S, DW-HL678S, DW-HL778S, DW-HL858S, DW-HL1008S, DW-HL530, DW-HL780

by Zhongke Meiling Cryogenics Company Limited.

Identity

Trade Name
Ultra-Low Temperature Freezer EUDAMED
Device Name
Ultra-Low Temperature Freezer EUDAMED
Model / Reference
DW-HL398, DW-HL528, DW-HL678, DW-HL778, DW-HL858, DW-HL1008, DW-HL398SA, DW-HL528SA, DW-HL678SA, DW-HL778SA, DW-HL858SA, DW-HL1008SA, DW-HL398S, DW-HL528S, DW-HL678S, DW-HL778S, DW-HL858S, DW-HL1008S, DW-HL530, DW-HL780 EUDAMED
/ EUDAMED

Identifiers

Primary DI / UDI-DI
06972244260448 EUDAMED
Basic UDI-DI
697224426DW-HLF3 EUDAMED
EMDN Code
Z121702 BLOOD AND BLOOD COMPONENTS FREEZERS EUDAMED

Classification

Device Class
Class IIa 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

Ultra-Low Temperature Freezer by Zhongke Meiling Cryogenics Company Limited. — Class IIa — 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
Zhongke Meiling Cryogenics Company Limited.
EUDAMED SRN
CN-MF-000034599
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (1)

  • EUDAMED ec5da149-4f46-4ddd-8eb1-6570c9e1c2f5 61 fields · synced Jun 18, 2026