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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-HL780Model DW-FL528, DW-FL678, DW-FL778, DW-FL1008, DW-FL528C, DW-FL678C, DW-FL778C, DW-FL1008C

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
DW-FL528, DW-FL678, DW-FL778, DW-FL1008, DW-FL528C, DW-FL678C, DW-FL778C, DW-FL1008C EUDAMED

Identifiers

Primary DI / UDI-DI
06972244260394 EUDAMED
06972244260257 EUDAMED
06972244260462 EUDAMED
06972244260424 EUDAMED
06972244262671 EUDAMED
06972244264231 EUDAMED
06972244260486 EUDAMED
06972244260349 EUDAMED
06972244260240 EUDAMED
06972244260455 EUDAMED
06972244260363 EUDAMED
06972244260318 EUDAMED
06972244260332 EUDAMED
06972244260387 EUDAMED
06972244260530 EUDAMED
06972244263845 EUDAMED
06972244262749 EUDAMED
06972244260400 EUDAMED
06972244267225 EUDAMED
06972244260523 EUDAMED
06972244265757 EUDAMED
06972244260356 EUDAMED
Basic UDI-DI
697224426DW-HLF3 EUDAMED
697224426DW-FLEV 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 (22)

  • EUDAMED 02133b4b-ff17-4034-97d6-10e9da9c093f 61 fields · synced Aug 3, 2026
  • EUDAMED 7257b91a-9c50-4f06-b651-087ed8362a77 61 fields · synced May 16, 2026
  • EUDAMED 6b098da7-b2ec-450c-8770-4d20dee2bf20 61 fields · synced May 16, 2026
  • EUDAMED ceac15ad-ebf3-463a-a313-312061368553 61 fields · synced May 17, 2026
  • EUDAMED 99846d15-faf2-4956-aee3-59059e06f450 61 fields · synced May 17, 2026
  • EUDAMED 9db965f4-8b7a-4e62-adca-4b871c0b38b2 61 fields · synced May 17, 2026
  • EUDAMED abd9014a-f4a1-4986-a0ce-58ae445f8247 61 fields · synced May 17, 2026
  • EUDAMED 135155fb-7964-467d-9ab0-443da84d9716 61 fields · synced May 17, 2026
  • EUDAMED 9dcffbf6-1da1-46ed-8991-b92181cdb44a 61 fields · synced May 17, 2026
  • EUDAMED 66780025-d49d-4522-9886-ebe0e4041575 61 fields · synced May 17, 2026
  • EUDAMED 8ce21a31-2255-4561-8e3c-55c1b1602de4 61 fields · synced May 18, 2026
  • EUDAMED f5c25193-2cba-4d61-9fe1-802bf68d4795 61 fields · synced May 18, 2026
  • EUDAMED f130390e-9a49-48be-af57-a19eb091c524 61 fields · synced May 18, 2026
  • EUDAMED 630cfc6c-ef09-47c2-b547-1d42768d422b 61 fields · synced May 18, 2026
  • EUDAMED d3e77e08-b83d-4ca9-a77b-c14b0087c7f1 61 fields · synced May 18, 2026
  • EUDAMED 4bcdb434-c16f-474d-a1a8-20e8793a2080 61 fields · synced May 18, 2026
  • EUDAMED 48f92020-5846-4304-bd93-9958597118e1 61 fields · synced May 18, 2026
  • EUDAMED 88c179d1-69a2-4a13-9fed-5b8ee347ff63 61 fields · synced May 18, 2026
  • EUDAMED 1f71693b-14a1-4e30-a87b-8a6c41265fbe 61 fields · synced May 18, 2026
  • EUDAMED 32e5452d-bb05-41bd-bc91-ee6238f285cf 61 fields · synced May 19, 2026
  • EUDAMED edbce3b3-0435-43c0-a7a1-18523be01aed 61 fields · synced May 19, 2026
  • EUDAMED c10b0543-8323-4130-8b0d-6da4da524fc0 61 fields · synced May 19, 2026