Identity
- Trade Name
- Haier FDA UDI
- Generic Name
- Blood refrigerator FDA UDI
- Device Name
- Blood Bank Refrigerator EUDAMEDFDA UDI
- Model / Reference
- HXC-1369 EUDAMEDFDA UDI
- Description
- Blood Bank Refrigerator FDA UDI
Identifiers
- Catalog Number
- HXC-1369 FDA UDI
- Primary DI / UDI-DI
- 06949573520871 EUDAMEDFDA UDI
- Basic UDI-DI
- 6949573502ND5001CX EUDAMED
- FDA Product Code
- KSE FDA UDI
- EMDN Code
- Z121701 BLOOD BANKS REFRIGERATORS EUDAMED
- GMDN Term
- Blood refrigerator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9700 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood refrigerator
Haier by Qingdao Haier Biomedical Co Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Blood refrigerator.
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- Horizon Series™ — HELMER Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Qingdao Haier Biomedical Co Ltd
Sources (2)
- FDA UDI be951800-9f03-4f26-98d8-dbc3218ead23 34 fields · synced Jul 13, 2026
- EUDAMED b71157cf-8403-4de0-bf95-d94fe2d3b9ce 61 fields · synced Jul 13, 2026