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Rtx-12
EUDAMEDClass I (EU MDR)
Ref RTX-12
by Jessop Precision Products, Inc (Trading as The Suremark Company)
Identity
- Trade Name
- RTX-12 EUDAMED
- Device Name
- TM RADTAT SERIES EUDAMED
- Model / Reference
- RTX-12 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B971RTX121 EUDAMED
- Basic UDI-DI
- ++B971TheramarkLL EUDAMED
- EMDN Code
- V9004 SKIN MARKING DERMOGRAPHIC PENCILS AND PENS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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
Rtx-12 by Jessop Precision Products, Inc (Trading as The Suremark Company) — 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 | ++B971TheramarkLL | Class I | Active |
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Manufacturer
- EUDAMED SRN
- US-MF-000013348
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (1)
- EUDAMED 4a2213b8-ec81-443d-b971-46794ea290a5 61 fields · synced Oct 7, 2026