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THALIS Flex- Peripheral Stent Implantation System
EUDAMEDClass IIb (EU MDR)
Ref 100 TFX 36-08 5F
Identity
- Trade Name
- THALIS Flex- Peripheral Stent Implantation System EUDAMED
- Model / Reference
- 100 TFX 36-08 5F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04051649251908 EUDAMED
- Basic UDI-DI
- B-04051649251908 EUDAMED
- EMDN Code
- P070402020102 NON-STAINLESS STEEL PERIPHERAL VASCULAR BARE METAL STENTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
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
THALIS Flex- Peripheral Stent Implantation System by QualiMed Innovative Medizinprodukte GmbH — Class IIb — MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04051649251908 | Class IIb | Active |
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Manufacturer
- Manufacturer
- QualiMed Innovative Medizinprodukte GmbH
- EUDAMED SRN
- DE-MF-000008095
Sources (1)
- EUDAMED 1ef2e0ad-f235-4d2d-b601-9d33e0a6ab66 61 fields · synced Jun 20, 2026