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Non-sterile Single Use Warming Blanket
EUDAMEDFDA UDIClass I (EU MDR)
Ref IOB-005
Identity
- Trade Name
- Non-sterile Single Use Warming Blanket EUDAMEDIOB FDA UDI
- Generic Name
- Circulating-air whole-body heating system control unit FDA UDI
- Device Name
- Non-sterile Single Use Warming Blanket EUDAMED
- Model / Reference
- IOB-005 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06951013001130 EUDAMEDFDA UDI
- Basic UDI-DI
- 69510130NSWBRA EUDAMED
- FDA Product Code
- DWJ FDA UDI
- EMDN Code
- T030301 AIR FLOW BLANKETS EUDAMED
- GMDN Term
- Circulating-air whole-body heating system control unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5900 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Non-sterile Single Use Warming Blanket by Jiangmen Dacheng Medical Equipment Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69510130NSWBRA | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Jiangmen Dacheng Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000026651
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 8cbf9157-ee51-4046-9b48-f7468ae82a69 61 fields · synced Oct 6, 2026
- FDA UDI 5ab3b0b6-afdf-42d5-957e-dd2f0310884c 32 fields · synced May 30, 2026