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QualiMed Innovative Medizinprodukte GmbH

Germany·DE-MF-000008095

Last updated September 18, 2026

What QualiMed Innovative Medizinprodukte GmbH makes

QualiMed Innovative Medizinprodukte GmbH manufactures peripheral vascular stent systems, including balloon-expandable stents (QBX) designed for treating arterial narrowing or blockages in peripheral blood vessels, as well as a self-expanding stent system (PSpp) for similar applications. The company also produces percutaneous transluminal angioplasty (PTA) balloon catheters (PVQ) used to widen narrowed or obstructed arteries. These devices are intended for use in interventional radiology and cardiology procedures.

The company’s products are classified under EU Medical Device Regulations as Class III (high-risk stents) and Class IIa/IIb (moderate-risk catheters and stents), with all relevant devices listed in the EU’s eudamed registry. The manufacturer is based in Germany and adheres to EU regulatory requirements for medical device authorisation.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does QualiMed Innovative Medizinprodukte GmbH manufacture?

QualiMed Innovative Medizinprodukte GmbH specialises in peripheral vascular devices. Their portfolio includes balloon-expandable stent systems (QBX) for treating arterial narrowing or blockages in peripheral blood vessels, a self-expanding stent system (PSpp) for similar applications, and PTA balloon catheters (PVQ) used to widen narrowed or obstructed arteries. These devices are designed for use in interventional radiology and cardiology procedures.

Where is QualiMed Innovative Medizinprodukte GmbH based?

The company is headquartered in Germany, adhering to EU regulatory standards for medical device development and manufacturing.

Which regulatory registries list QualiMed’s medical devices?

All relevant devices manufactured by QualiMed Innovative Medizinprodukte GmbH are listed in the EU’s eudamed registry, which is the official database for medical device information under EU Medical Device Regulations.

How are QualiMed’s devices classified under EU regulations?

QualiMed’s devices fall under different risk classifications: their stents (QBX and PSpp) are classified as Class III, which includes high-risk implants requiring stringent regulatory oversight. Their PTA balloon catheters (PVQ) are classified as Class IIa or IIb, depending on their specific design and intended use, indicating moderate risk.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: Germany
Address: 16, Boschstraße, Winsen (Luhe), Germany
Website: www.qualimed.de
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +49 4171 6578 171
PRRC Contact: Manfred Gülcher
EUDAMED SRN: DE-MF-000008095
FDA FEI Number: —
DUNS Number: —

Catalogue (1053)

Page 2 of 22

Device	Model / Reference	Registries	Class	Status
ISTAR PTCA Balloon Catheter	391511	EUDAMED	Class III	Active
PROPOS XS Peripheral Balloon Expandable Stent System	13 QBX 060175F	EUDAMED	Class IIb	Active
THALIS Flex 6F Peripheral Stent Implantation System	80 TFX 57-08 6F	EUDAMED	Class IIb	Active
Peripheral Vascular Self Expanding Stent System (PS)	12 AHS 07100	EUDAMED	Class IIb	Active
PEGASUS PTCA Balloon Catheter	PC2715	EUDAMED	Class III	Active
PTA Balloon Catheter (PVQ)	12PVQ080060APH	EUDAMED	Class IIa	Active
PEGASUS PTCA Balloon Catheter	PC4020	EUDAMED	Class III	Active
PROPOS S 6F Peripheral Balloon Expandable Stent System	08 QBX 080576F	EUDAMED	Class IIb	Active
PTA Balloon Catheter (PVQ)	15PVQ040020APO	EUDAMED	Class IIa	Active
Peripheral Balloon Expandable Stent System (QBX)	15 QBX 100575F	EUDAMED	Class IIb	Active
Peripheral Vascular Self Expanding Stent System (PSpp)	08 APS 07060	EUDAMED	Class IIb	Active
PROPOS S 6F Peripheral Balloon Expandable Stent System	12 QBX 090366F	EUDAMED	Class IIb	Active
VMAX Aspiration Catheter	VX7HI3	EUDAMED	Class III	Active
THALIS Flex 6F Peripheral Stent Implantation System	50 TFX 57-15 6F	EUDAMED	Class IIb	Active
PTA Balloon Catheter (PVQ)	15PVQ080060BPO5F	EUDAMED	Class IIa	Active
Peripheral Vascular Self Expanding Stent System (PSpp)	08 APS 08150	EUDAMED	Class IIb	Active
PTA Balloon Catheter (PVQ)	08PVQ020220BPO	EUDAMED	Class IIa	Active
Peripheral Vascular Self Expanding Stent System (PSpp)	12 APS 07200	EUDAMED	Class IIb	Active
PTA Balloon Catheter (PVQ)	15PVQ040120APO	EUDAMED	Class IIa	Active
TALON Minor 6F Peripheral Balloon Expandable Stent System	12 QBX 100576F	EUDAMED	Class IIb	Active
PTA Balloon Catheter (PVQ)	15PVQ015280CPO	EUDAMED	Class IIa	Active
PTA Balloon Catheter (PVQ)	12PVQ040100APO	EUDAMED	Class IIa	Active
THALIS Flex 6F Peripheral Stent Implantation System	70 TFX 17-12 6F	EUDAMED	Class IIb	Active
PYXIS-c PTCA Balloon Catheter	PC1512	EUDAMED	Class III	Active
PYXIS-c PTCA Balloon Catheter	PC3240	EUDAMED	Class III	Active
PTA Balloon Catheter (PVQ)	15PVQ050280CPO	EUDAMED	Class IIa	Active
Peripheral Balloon Expandable Stent System (QBX)	15 QBX 100365F	EUDAMED	Class IIb	Active
TALON Minor 6F Peripheral Balloon Expandable Stent System	12 QBX 100266F	EUDAMED	Class IIb	Active
PTA Balloon Catheter (PVQ)	12PVQ012100CPO	EUDAMED	Class IIa	Active
PTCA Balloon Catheter (PC)	PC4516	EUDAMED	Class III	Active
Peripheral Vascular Self Expanding Stent System (PS)	12 AHS 06060	EUDAMED	Class IIb	Active
Peripheral Vascular Self Expanding Stent System (PSpp)	08 APS 10040	EUDAMED	Class IIb	Active
PTA Balloon Catheter (PVQ)	08PVQ080080APO	EUDAMED	Class IIa	Active
PTA Balloon Catheter (PVQ)	15PVQ100060APO	EUDAMED	Class IIa	Active
TALON Minor- Peripheral Balloon Expandable Stent System	13 QBX 050175F	EUDAMED	Class IIb	Active
JUTURNA-c PTCA Balloon Catheter	PC4016	EUDAMED	Class III	Active
PROPOS S 6F Peripheral Balloon Expandable Stent System	15 QBX 080266F	EUDAMED	Class IIb	Active
PEGASUS PTCA Balloon Catheter	PC2216	EUDAMED	Class III	Active
PYXIS-c PTCA Balloon Catheter	PC2725	EUDAMED	Class III	Active
Peripheral Balloon Expandable Stent System (QBX)	08 QBX 070176F	EUDAMED	Class IIb	Active
TALON Minor 6F Peripheral Balloon Expandable Stent System	12 QBX 100366F	EUDAMED	Class IIb	Active
PTA Balloon Catheter (PVQ)	12PVQ070020APH	EUDAMED	Class IIa	Active
PEGASUS PTCA Balloon Catheter	PC2225	EUDAMED	Class III	Active
Peripheral Balloon Expandable Stent System (QBX)	13 QBX 100575F	EUDAMED	Class IIb	Active
LITUS Xi 6F Peripheral Balloon Expandable Stent System	12 QBX 090266F	EUDAMED	Class IIb	Active
THALIS Flex- Peripheral Stent Implantation System	100 TFX 36-08 5F	EUDAMED	Class IIb	Active
PTCA Balloon Catheter (PC)	PC4040	EUDAMED	Class III	Active
PTA Balloon Catheter (PVQ)	08PVQ030100BPO	EUDAMED	Class IIa	Active
PTA Balloon Catheter (PVQ)	12PVQ040280APO	EUDAMED	Class IIa	Active
PTA Balloon Catheter (PVQ)	12PVQ050120APO	EUDAMED	Class IIa	Active

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