Identity
- Trade Name
- TCmatt NEOmulti EUDAMEDTCmatt FDA UDI
- Generic Name
- External circulating-fluid core temperature regulation system pad, reusable FDA UDI
- Device Name
- temperature regulation system pad EUDAMEDMattress to be used with TECOtherm NEO hypothermia system for full body temperature control of patients, principally newborns and infants. FDA UDI
- Model / Reference
- 6426801 EUDAMEDNEOmulti FDA UDI
- Description
- Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of patients, principally newborns and infants. FDA UDI
Identifiers
- Catalog Number
- 6426801 FDA UDI
- Primary DI / UDI-DI
- 04260647540031 EUDAMEDFDA UDI
- Basic UDI-DI
- 4260647540031WE EUDAMED
- Direct Marketing DI
- 04260647540031 EUDAMED
- FDA Product Code
- FOH FDA UDI
- EMDN Code
- V0299 NEONATOLOGY AND PAEDIATRIC DEVICES - OTHER EUDAMED
- GMDN Term
- External circulating-fluid core temperature regulation system pad, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5560 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Assistive crawler/mobility board
TCmatt NEOmulti by Tec Com Medizintechnik Gmbh — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 4260647540031WE | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Tec Com Medizintechnik GmbH
- EUDAMED SRN
- DE-MF-000004978
Sources (2)
- EUDAMED 370bf70d-9de1-447d-a9f3-99ca39c3a565 61 fields · synced Jul 18, 2026
- FDA UDI f47f1f92-5b84-4efe-bce4-ff70a6f87126 35 fields · synced May 30, 2026