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Peripheral Vascular Self Expanding Stent System (PSpp)
EUDAMEDClass IIb (EU MDR)
Ref 12 APS 05120
Identity
- Trade Name
- Peripheral Vascular Self Expanding Stent System (PSpp) EUDAMED
- Model / Reference
- 12 APS 05120 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04051649245891 EUDAMED
- Basic UDI-DI
- B-04051649245891 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
Peripheral Vascular Self Expanding Stent System (PSpp) 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-04051649245891 | Class IIb | Active |
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Manufacturer
- Manufacturer
- QualiMed Innovative Medizinprodukte GmbH
- EUDAMED SRN
- DE-MF-000008095
Sources (1)
- EUDAMED 5e7c723d-08bc-46f2-96ed-41ad088c3e29 61 fields · synced Jun 18, 2026