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Mistral-Air® Premium Warming Suit S
EUDAMEDFDA UDIClass I (EU MDR)
Ref MA1610Model MA0510
Identity
- Trade Name
- Mistral-Air® Premium Warming Suit S EUDAMEDMistral-Air FDA UDI
- Generic Name
- Hypothermia-prevention whole-body suit FDA UDI
- Device Name
- Mistral-Air® Tube EUDAMEDMISTRAL-AIR PREMIUM SUIT, S MA PREMIUM SUIT, S, SILVER/BLUE, 1/BG, 10 BG/CS NONWOVEN FDA UDI
- Model / Reference
- MA0510 EUDAMEDMA1610 EUDAMEDFDA UDI
- Description
- MISTRAL-AIR PREMIUM SUIT, S MA PREMIUM SUIT, S, SILVER/BLUE, 1/BG, 10 BG/CS NONWOVEN FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18719867000243 EUDAMEDFDA UDI
- Basic UDI-DI
- 8719867EMDNT030301KX EUDAMED
- FDA Product Code
- DWJ FDA UDI
- EMDN Code
- T030301 AIR FLOW BLANKETS EUDAMED
- GMDN Term
- Hypothermia-prevention whole-body suit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.5900 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Mistral-Air® Premium Warming Suit S by The Surgical Company International B.V. — 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 | 8719867EMDNT030301KX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- The Surgical Company International B.V.
- EUDAMED SRN
- NL-MF-000001973
Sources (2)
- EUDAMED d0abb3b1-d5a7-4a3b-9e05-4b5d8e0e99e7 61 fields · synced Jun 19, 2026
- FDA UDI e48d2280-2ecc-4227-9a5c-46c81ed4da15 34 fields · synced May 30, 2026