Identity
- Trade Name
- TCW15RSDD EUDAMEDTCW 15R SDD EUDAMED
- Device Name
- Vaccine refrigerators and vaccine/ ice-pack freezers EUDAMEDVaccine refrigerators and vaccine/ ice or water pack freezers EUDAMED
- Model / Reference
- 991.2357.** EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05450104536311 EUDAMED
- Basic UDI-DI
- 05450104511172AT EUDAMED
- EMDN Code
- V0899 MEDICAL SUPPORT EQUIPMENT - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Luxembourg EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Tcw15rsdd by B Medical Systems S.à r.l. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 05450104511172AT | Class I | Active |
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Manufacturer
- Manufacturer
- B Medical Systems S.à r.l.
- EUDAMED SRN
- LU-MF-000000128
Sources (2)
- EUDAMED b13380e9-3c07-439d-9251-5819c977a5db 61 fields · synced Jul 25, 2026
- EUDAMED ee94e700-9dbf-4a21-b193-85e5b7e20e9f 61 fields · synced Jul 25, 2026