Identity
- Trade Name
- Thornhill Research Inc. EUDAMEDMADM FDA UDI
- Generic Name
- Anaesthesia unit, mobile FDA UDI
- Device Name
- MADM™ Anesthesia Delivery Module EUDAMEDAssy, MADM FDA UDI
- Model / Reference
- 124198 EUDAMED124641 FDA UDI
- Description
- Assy, MADM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10807141000091 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10807141000091 EUDAMED
- 510(k) Number
- K140264 FDA UDI
- FDA Product Code
- CCK FDA UDIBSZ FDA UDI
- EMDN Code
- Z1203010101 ANAESTHESIA DEVICES EUDAMED
- GMDN Term
- Anaesthesia unit, mobile FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.1400 FDA UDI868.5160 FDA UDI
- Market of Registration
- Netherlands 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Thornhill Research Inc. by Thornhill Research Inc — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10807141000091 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Thornhill Research Inc
- EUDAMED SRN
- CA-MF-000039470
- Authorised Representative
- Freyr Regulatory GmbH DE-AR-000047121
Sources (2)
- EUDAMED 547860ce-2fba-4170-8e61-8f3c6492a9eb 61 fields · synced Jun 1, 2026
- FDA UDI 8a99fa99-f3fd-484f-bb4a-b8d9b2b968b9 35 fields · synced May 30, 2026