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Ultra-Low Temperature Freezer
EUDAMEDClass IIa (EU MDR)
Ref /Model DW-FL528, DW-FL678, DW-FL778, DW-FL1008, DW-FL528C, DW-FL678C, DW-FL778C, DW-FL1008C
Identity
- Trade Name
- Ultra-Low Temperature Freezer EUDAMED
- Device Name
- Ultra-Low Temperature Freezer EUDAMED
- Model / Reference
- DW-FL528, DW-FL678, DW-FL778, DW-FL1008, DW-FL528C, DW-FL678C, DW-FL778C, DW-FL1008C EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972244260301 EUDAMED
- Basic UDI-DI
- 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697224426DW-FLEV | Class IIa | Active |
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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 1b7412e1-95a4-44a8-93d7-9754762649f1 61 fields · synced Jun 18, 2026