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PTA Balloon Catheter (PVQ)
EUDAMEDClass IIa (EU MDR)
Ref 15PVQ050200APORef 08PVQ050200APORef 08PVQ060020BSDRef 12PVQ050020APHRef 12PVQ015120CPORef 15PVQ012080CPORef 12PVQ090060APHRef 15PVQ050170CPORef 15PVQ050030APHRef 15PVQ030015APORef 08PVQ030200BPORef 15PVQ100030BPO5FRef 15PVQ070280APORef 15PVQ012220CPORef 08PVQ030010BPORef 12PVQ030080APORef 15PVQ012100CPORef 15PVQ040010CPORef 15PVQ040010APORef 08PVQ080040APORef 08PVQ090120APORef 12PVQ020080CPORef 12PVQ030040APORef 15PVQ040280CPORef 15PVQ030030CPORef 08PVQ050200BPORef 15PVQ060040APHRef 15PVQ080120APORef 12PVQ030040CPORef 08PVQ060015APORef 08PVQ100060APHRef 15PVQ060200APORef 08PVQ070030BPO5FRef 08PVQ070060BPO5FRef 13PVQ090040BPO5FRef 15PVQ020120CPORef 13PVQ040015BPORef 12PVQ060120APORef 12PVQ100120APORef 12PVQ030220APORef 12PVQ090100APORef 08PVQ090030BPO5FRef 08PVQ020120BPORef 12PVQ060010APORef 12PVQ015015CPORef 08PVQ090015APORef 15PVQ050220CPORef 15PVQ020030CPORef 13PVQ030010BPORef 08PVQ040030BPORef 12PVQ030170CPO
Identity
- Trade Name
- PTA Balloon Catheter (PVQ) EUDAMED
- Model / Reference
- 15PVQ050200APO EUDAMED08PVQ050200APO EUDAMED08PVQ060020BSD EUDAMED12PVQ050020APH EUDAMED12PVQ015120CPO EUDAMED15PVQ012080CPO EUDAMED12PVQ090060APH EUDAMED15PVQ050170CPO EUDAMED15PVQ050030APH EUDAMED15PVQ030015APO EUDAMED08PVQ030200BPO EUDAMED15PVQ100030BPO5F EUDAMED15PVQ070280APO EUDAMED15PVQ012220CPO EUDAMED08PVQ030010BPO EUDAMED12PVQ030080APO EUDAMED15PVQ012100CPO EUDAMED15PVQ040010CPO EUDAMED15PVQ040010APO EUDAMED08PVQ080040APO EUDAMED08PVQ090120APO EUDAMED12PVQ020080CPO EUDAMED12PVQ030040APO EUDAMED15PVQ040280CPO EUDAMED15PVQ030030CPO EUDAMED08PVQ050200BPO EUDAMED15PVQ060040APH EUDAMED15PVQ080120APO EUDAMED12PVQ030040CPO EUDAMED08PVQ060015APO EUDAMED08PVQ100060APH EUDAMED15PVQ060200APO EUDAMED08PVQ070030BPO5F EUDAMED08PVQ070060BPO5F EUDAMED13PVQ090040BPO5F EUDAMED15PVQ020120CPO EUDAMED13PVQ040015BPO EUDAMED12PVQ060120APO EUDAMED12PVQ100120APO EUDAMED12PVQ030220APO EUDAMED12PVQ090100APO EUDAMED08PVQ090030BPO5F EUDAMED08PVQ020120BPO EUDAMED12PVQ060010APO EUDAMED12PVQ015015CPO EUDAMED08PVQ090015APO EUDAMED15PVQ050220CPO EUDAMED15PVQ020030CPO EUDAMED13PVQ030010BPO EUDAMED08PVQ040030BPO EUDAMED12PVQ030170CPO EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04051649095908 EUDAMED04051649092549 EUDAMED04051649238589 EUDAMED04051649259324 EUDAMED04051649238848 EUDAMED04051649238985 EUDAMED04051649259546 EUDAMED04051649235939 EUDAMED04051649259621 EUDAMED04051649094666 EUDAMED04051649237186 EUDAMED04051649236929 EUDAMED04051649096172 EUDAMED04051649239050 EUDAMED04051649237087 EUDAMED04051649093584 EUDAMED04051649238992 EUDAMED04051649235663 EUDAMED04051649094567 EUDAMED04051649091740 EUDAMED04051649092235 EUDAMED04051649234765 EUDAMED04051649093348 EUDAMED04051649235816 EUDAMED04051649235533 EUDAMED04051649237445 EUDAMED04051649245754 EUDAMED04051649095588 EUDAMED04051649234901 EUDAMED04051649091368 EUDAMED04051649259317 EUDAMED04051649095922 EUDAMED04051649237612 EUDAMED04051649237636 EUDAMED04051649236738 EUDAMED04051649235427 EUDAMED04051649236257 EUDAMED04051649093881 EUDAMED04051649093928 EUDAMED04051649155367 EUDAMED04051649093799 EUDAMED04051649237698 EUDAMED04051649237032 EUDAMED04051649092921 EUDAMED04051649238770 EUDAMED04051649091399 EUDAMED04051649235953 EUDAMED04051649235373 EUDAMED04051649236110 EUDAMED04051649237247 EUDAMED04051649234970 EUDAMED
- Basic UDI-DI
- B-04051649095908 EUDAMEDB-04051649092549 EUDAMEDB-04051649238589 EUDAMEDB-04051649259324 EUDAMEDB-04051649238848 EUDAMEDB-04051649238985 EUDAMEDB-04051649259546 EUDAMEDB-04051649235939 EUDAMEDB-04051649259621 EUDAMEDB-04051649094666 EUDAMEDB-04051649237186 EUDAMEDB-04051649236929 EUDAMEDB-04051649096172 EUDAMEDB-04051649239050 EUDAMEDB-04051649237087 EUDAMEDB-04051649093584 EUDAMEDB-04051649238992 EUDAMEDB-04051649235663 EUDAMEDB-04051649094567 EUDAMEDB-04051649091740 EUDAMEDB-04051649092235 EUDAMEDB-04051649234765 EUDAMEDB-04051649093348 EUDAMEDB-04051649235816 EUDAMEDB-04051649235533 EUDAMEDB-04051649237445 EUDAMEDB-04051649245754 EUDAMEDB-04051649095588 EUDAMEDB-04051649234901 EUDAMEDB-04051649091368 EUDAMEDB-04051649259317 EUDAMEDB-04051649095922 EUDAMEDB-04051649237612 EUDAMEDB-04051649237636 EUDAMEDB-04051649236738 EUDAMEDB-04051649235427 EUDAMEDB-04051649236257 EUDAMEDB-04051649093881 EUDAMEDB-04051649093928 EUDAMEDB-04051649155367 EUDAMEDB-04051649093799 EUDAMEDB-04051649237698 EUDAMEDB-04051649237032 EUDAMEDB-04051649092921 EUDAMEDB-04051649238770 EUDAMEDB-04051649091399 EUDAMEDB-04051649235953 EUDAMEDB-04051649235373 EUDAMEDB-04051649236110 EUDAMEDB-04051649237247 EUDAMEDB-04051649234970 EUDAMED
- EMDN Code
- C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED
Classification
- Device Class
- Class IIa 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
Category: Peripheral angioplasty balloon catheter, basic
PTA Balloon Catheter (PVQ) by QualiMed Innovative Medizinprodukte GmbH — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral angioplasty balloon catheter, basic.
- Minerva PTA Balloon Dilatation Catheter — BrosMed Medical Co., Ltd. · Class IIa
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- Senri — KANEKA Corporation · Class IIa
- Jade PTA Balloon Dilatation Catheter — OrbusNeich Medical (ShenZhen) Co., Ltd. · Class II
- ZENFluxion — Zylox-Tonbridge Medical Technology Co., Ltd. · Class III
- Pacific™ Plus — MEDTRONIC, INC. · Class II
- Metacross OTW — KANEKA Corporation · Class IIa
- Armada — Abbott Vascular · Class II
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-04051649095908 | Class IIa | Active |
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Manufacturer
- Manufacturer
- QualiMed Innovative Medizinprodukte GmbH
- EUDAMED SRN
- DE-MF-000008095
Sources (51)
- EUDAMED 0c083fe1-0c3d-4389-82e4-150b2c9499d9 61 fields · synced Oct 7, 2026
- EUDAMED 1cd38d26-f37d-46bb-a670-48a8be1f1f70 61 fields · synced May 11, 2026
- EUDAMED 24c3b0b9-ccef-45b0-bd78-9d0f1045ee07 61 fields · synced May 11, 2026
- EUDAMED 2b22c8e9-d927-41d7-b3b9-a5c86d8d42f5 61 fields · synced May 11, 2026
- EUDAMED 39f1c95e-e23c-4d21-9ee5-0f085886c229 61 fields · synced May 11, 2026
- EUDAMED 410f1773-ea46-447e-9181-3551da213d5c 61 fields · synced May 11, 2026
- EUDAMED 4f8edffd-4742-4cfc-81ec-14de6ce2149a 61 fields · synced May 11, 2026
- EUDAMED 628c8b5d-50c7-45c1-ac2f-323dea5e8e2a 61 fields · synced May 11, 2026
- EUDAMED 6877e969-4c4a-4489-a005-cbb841a98301 61 fields · synced May 11, 2026
- EUDAMED 712714ea-7df9-45de-a3da-109ff6549e2b 61 fields · synced May 11, 2026
- EUDAMED bad9f258-8067-44f5-bbca-4be4684d502a 61 fields · synced May 11, 2026
- EUDAMED bb43b282-4ba6-4d59-a518-6bb9a9f990ed 61 fields · synced May 11, 2026
- EUDAMED b830ecf2-455b-4fcc-9085-51c5127cbd9b 61 fields · synced May 11, 2026
- EUDAMED cbb43ec3-f759-4e60-bcef-aefd4882ccb6 61 fields · synced May 11, 2026
- EUDAMED 15831d2f-7074-4f9d-be5c-c75b5241050d 61 fields · synced May 11, 2026
- EUDAMED 15a2491b-309b-407e-8a32-ab0b44325621 61 fields · synced May 11, 2026
- EUDAMED 1648c5d8-fa27-4920-a404-df40dcb44dbb 61 fields · synced May 11, 2026
- EUDAMED 18be01b2-9fec-455d-91dd-4713eee991c3 61 fields · synced May 11, 2026
- EUDAMED 19e66b07-bcba-4ba7-a566-bac9c697bc95 61 fields · synced May 11, 2026
- EUDAMED 847d2343-0462-4dc1-8c45-21952edf7361 61 fields · synced May 16, 2026
- EUDAMED e36033d3-97dd-4d69-960a-bf102f056152 61 fields · synced May 16, 2026
- EUDAMED 68f58b17-d330-4a82-8ed2-0380f39ea2f1 61 fields · synced May 16, 2026
- EUDAMED adf7d8a4-2e7a-4725-9145-12e4f37c4767 61 fields · synced May 16, 2026
- EUDAMED 84d109a9-b358-4484-ab58-a1496be41c22 61 fields · synced May 16, 2026
- EUDAMED 6c78aa27-2b99-480d-950a-19d09a7f61e5 61 fields · synced May 16, 2026
- EUDAMED 5dd830a2-549f-4df1-89e5-867730fdacaf 61 fields · synced May 16, 2026
- EUDAMED 837ee54c-4d81-4e99-b9c1-93e135da966a 61 fields · synced May 16, 2026
- EUDAMED a65ce03b-4b9f-4c0f-819d-2621b8802914 61 fields · synced May 16, 2026
- EUDAMED c20bc0e7-0426-4ff6-9469-8033c8736b9b 61 fields · synced May 16, 2026
- EUDAMED f654bcc7-9ec5-4c9c-a6bf-b599de2237d5 61 fields · synced May 16, 2026
- EUDAMED 21ef0d08-ade3-4ba2-9905-b051ce1e34b5 61 fields · synced May 16, 2026
- EUDAMED de70ff49-079c-420e-80b9-db1dcbaf5c01 61 fields · synced May 16, 2026
- EUDAMED 08217b58-a38f-43eb-9c1e-6a2984d47e5e 61 fields · synced May 16, 2026
- EUDAMED bc7916f4-ec3b-4191-a8c8-28adcde2e563 61 fields · synced May 16, 2026
- EUDAMED e05116ab-a1cf-487a-830a-85c2bb2ff8e5 61 fields · synced May 16, 2026
- EUDAMED e0177c07-57ba-4971-85f8-2b30ecdcb8ba 61 fields · synced May 16, 2026
- EUDAMED 6bec88e7-40ee-44c1-8fe4-801390a21bc5 61 fields · synced May 16, 2026
- EUDAMED f3584c30-7ac4-4ced-af27-b78e22483620 61 fields · synced May 16, 2026
- EUDAMED 60d65982-a1d7-4adc-ba1e-2049ba3d3761 61 fields · synced May 16, 2026
- EUDAMED 78b05dd2-777f-4eac-94ee-67603f9ecf3a 61 fields · synced May 16, 2026
- EUDAMED e63d6b56-ecab-4161-a322-26355b50af52 61 fields · synced May 16, 2026
- EUDAMED 0a8bb7a5-a9b9-489c-8870-38e6e6ee0d0a 61 fields · synced May 16, 2026
- EUDAMED 558cc49b-27eb-463c-b1c9-2e74e8dfe077 61 fields · synced May 16, 2026
- EUDAMED bd30bb79-03b5-4b86-bcd1-acbf34f0794c 61 fields · synced May 16, 2026
- EUDAMED 5ce49ef4-1193-4eaa-9999-5c867a5b6037 61 fields · synced May 16, 2026
- EUDAMED 36cae169-9745-4a45-b954-1cbbdd093158 61 fields · synced May 16, 2026
- EUDAMED 455ca6cb-4fa2-467e-8aac-c3b100ea7da1 61 fields · synced May 16, 2026
- EUDAMED 21839abe-0b10-49f4-b26e-a45802fb1abe 61 fields · synced May 16, 2026
- EUDAMED 7370f575-cd3b-4610-b4ec-6976e3a79f43 61 fields · synced May 16, 2026
- EUDAMED cbd88024-8fc0-4139-a545-51f4a8422fb3 61 fields · synced May 16, 2026
- EUDAMED fc43d107-ef20-43c3-84b7-7faea633f549 61 fields · synced May 16, 2026