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Meling Biomedical
EUDAMEDClass IIa (EU MDR)
Ref ML9039928Model DW-HL1008SARef /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
Identity
- Trade Name
- Meling Biomedical EUDAMEDUltra-Low Temperature Freezer EUDAMED
- Device Name
- Ultra-Low Temperature Freezer EUDAMED
- Model / Reference
- DW-HL1008SA EUDAMEDML9039928 EUDAMEDDW-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
- 06972244263975 EUDAMED
- Basic UDI-DI
- B-06972244263975 EUDAMED697224426DW-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
Meling Biomedical by Zhongke Meiling Cryogenics Company Limited. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06972244263975 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06972244263975 | 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 (2)
- EUDAMED 2bc52f9e-f40d-4d8e-a4c3-855d5e29086d 61 fields · synced Jul 23, 2026
- EUDAMED 6196bb23-be40-4ea5-80ee-13c12c82a2c0 61 fields · synced May 18, 2026