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Peripheral Balloon Expandable Stent System (QBX)
EUDAMEDClass IIb (EU MDR)
Ref 08 QBX 080265F
Identity
- Trade Name
- Peripheral Balloon Expandable Stent System (QBX) EUDAMED
- Model / Reference
- 08 QBX 080265F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04051649238374 EUDAMED
- Basic UDI-DI
- B-04051649238374 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 Balloon Expandable Stent System (QBX) 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-04051649238374 | Class IIb | Active |
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Manufacturer
- Manufacturer
- QualiMed Innovative Medizinprodukte GmbH
- EUDAMED SRN
- DE-MF-000008095
Sources (1)
- EUDAMED 7d9f3256-f510-4cc2-8340-2f66f6b5cb09 61 fields · synced Jun 18, 2026