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UNIDOS Romeo
EUDAMEDClass IIb (EU MDR)
Ref TN10053- AS
by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH
Identity
- Trade Name
- UNIDOS Romeo EUDAMED
- Device Name
- UNIDOS EUDAMED
- Model / Reference
- TN10053- AS EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EPTWTN10053YAS0 EUDAMED
- Basic UDI-DI
- ++EPTWAR411AC EUDAMED
- EMDN Code
- Z119002 DOSIMETERS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
UNIDOS Romeo by PTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbH — Class IIb — 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 | ++EPTWAR411AC | Class IIb | Active |
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Manufacturer
- EUDAMED SRN
- DE-MF-000005794
Sources (1)
- EUDAMED fd5ec3b1-25a2-4370-84d2-24004ae7da4a 61 fields · synced Jun 19, 2026