Identity
- Trade Name
- TECOtherm Wrabbit M EUDAMEDTECOtherm Wrabbit FDA UDI
- Generic Name
- Infant heat shield FDA UDI
- Device Name
- TECOtherm Wrabbit M EUDAMEDThe TECOtherm Wrabbit is designed as a disposable device to help prevent postnatal heat and water loss in premature and newborn infants. FDA UDI
- Model / Reference
- 928 21 10 EUDAMEDM FDA UDI
- Description
- The TECOtherm Wrabbit is designed as a disposable device to help prevent postnatal heat and water loss in premature and newborn infants. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260647540239 EUDAMEDFDA UDI
- Basic UDI-DI
- 4260647540239X8 EUDAMED
- FDA Product Code
- KME FDA UDI
- EMDN Code
- V0299 NEONATOLOGY AND PAEDIATRIC DEVICES - OTHER EUDAMED
- GMDN Term
- Infant heat shield FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6060 FDA UDI
- Market of Registration
- Germany 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
No
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
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
TECOtherm Wrabbit M 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 | 4260647540239X8 | 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 7e8e756d-99f1-409d-b385-e7231c427b4c 61 fields · synced Jun 18, 2026
- FDA UDI 34a38e76-c3a7-4c47-a743-e0bfdf1382b8 34 fields · synced May 30, 2026