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Mistral-Air® Surgical Access Plus Sterile
EUDAMEDFDA UDIClass I (EU MDR)
Ref MA2280
Identity
- Trade Name
- Mistral-Air® Surgical Access Plus Sterile EUDAMEDMistral-Air FDA UDI
- Generic Name
- External circulating-air core temperature regulation system pad, single-use FDA UDI
- Device Name
- Mistral-Air® Surgical Access Plus Sterile EUDAMEDMistral-Air Blanket, Surgical Access Plus (sterile) FDA UDI
- Model / Reference
- MA2280 EUDAMEDFDA UDI
- Description
- Mistral-Air Blanket, Surgical Access Plus (sterile) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18719867000823 EUDAMEDFDA UDI
- Basic UDI-DI
- 8719867EMDNT030301S6T EUDAMED
- FDA Product Code
- DWJ FDA UDI
- EMDN Code
- T030301 AIR FLOW BLANKETS EUDAMED
- GMDN Term
- External circulating-air core temperature regulation system pad, single-use 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Mistral-Air® Surgical Access Plus Sterile 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 | 8719867EMDNT030301S6T | 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 27e04938-a031-4012-803b-97687c083abe 61 fields · synced Jun 19, 2026
- FDA UDI 7541e210-a0ac-4441-92a8-e7e9f7a52b0d 33 fields · synced May 30, 2026