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Monitoring Lead Wires for Thymatron System IV 24" Leads Set of 9
EUDAMEDClass I (EU MDR)
Ref ELDSC-9
Identity
- Trade Name
- Monitoring Lead Wires for Thymatron System IV 24" Leads Set of 9 EUDAMED
- Device Name
- Monitoring Lead Wires for Thymatron System IV 24" Set of 9 EUDAMED
- Model / Reference
- ELDSC-9 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850298007072 EUDAMED
- Basic UDI-DI
- 0850298007079D EUDAMED
- EMDN Code
- C020599 CARDIAC DIAGNOSTIC DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Monitoring Lead Wires for Thymatron System IV 24" Leads Set of 9 by Somatics, LLC — 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 | 0850298007079D | Class I | Active |
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Manufacturer
- Manufacturer
- Somatics, LLC
- EUDAMED SRN
- US-MF-000011550
- Authorised Representative
- FBI Medizintechnik GmbH DE-AR-000009421
Sources (1)
- EUDAMED 6c833cd1-8736-449f-b7d4-14092e7f5a6c 61 fields · synced Jul 13, 2026