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TOF3D - Neuromuscular Transmission Monitor
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 2510091510(k) K212434
Identity
- Trade Name
- TOF3D - Neuromuscular Transmission Monitor EUDAMEDFDA UDI
- Generic Name
- Block-monitoring peripheral nerve electrical stimulation system FDA UDI
- Device Name
- TOF3D - Neuromuscular Transmission Monitor EUDAMED
- Model / Reference
- 2510091 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 2510091 FDA UDI
- Primary DI / UDI-DI
- 04255629200393 EUDAMEDFDA UDI
- Basic UDI-DI
- 42556292001016M4 EUDAMED
- 510(k) Number
- K212434 FDA UDI
- FDA Product Code
- KOI FDA UDI
- EMDN Code
- Z1203019001 NEUROMUSCULAR RELAXATION MONITORING EQUIPMENT EUDAMED
- GMDN Term
- Block-monitoring peripheral nerve electrical stimulation system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.2775 FDA UDI
- Market of Registration
- Portugal 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
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
Yes
FDA UDI
TOF3D - Neuromuscular Transmission Monitor by MIPM Mammendorfer Institut für Physik und Medizin GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250887 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K212434 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 42556292001016M4 | Class IIa | Active |
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Manufacturer
- EUDAMED SRN
- DE-MF-000007654
Sources (3)
- EUDAMED 455f7cb7-9801-4ec9-829d-a6742702afaa 85 fields · synced Jun 18, 2026
- FDA UDI 0db61980-e50b-4394-8068-aa3432b6f9b1 35 fields · synced May 30, 2026
- FDA 510(k) K250887 1 fields · synced May 18, 2026