Identity
- Device Name
- Ultra Low Temperature (ULT) Freezer EUDAMED
- Model / Reference
- DW-86L578S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949573516294 EUDAMED
- Basic UDI-DI
- 6949573502NA4003BT EUDAMED
- EMDN Code
- Z121702 BLOOD AND BLOOD COMPONENTS FREEZERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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 (ULT) Freezer by Qingdao Haier Biomedical Co., Ltd — 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 | 6949573502NA4003BT | Class IIa | Active |
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Manufacturer
- Manufacturer
- Qingdao Haier Biomedical Co., Ltd.
- EUDAMED SRN
- CN-MF-000020601
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED cfdaaafe-c358-4183-80af-89d09f716617 61 fields · synced Jun 20, 2026