Vitus

EUDAMED

Class III (EU MDR)

Ref VIT0300150085Ref VIT0400040150Ref VIT0250040150Ref VIT0250150150Ref VIT0200080150Ref VIT0250120085Ref VIT0400080085Ref VIT0250120150Ref VIT0700150150Ref VIT0400040085Ref VIT0600040085Ref VIT0300080150Ref VIT0300080085Ref VIT0400060150Ref VIT0500080150Ref VIT0250080085Ref VIT0700080150Ref VIT0600150150Ref VIT0200150085Ref VIT0600080085Ref VIT0400120150Ref VIT0500120085Ref VIT0250150085Ref VIT0200080085Ref VIT0700080085Ref VIT0200120085Ref VIT0600080150Ref VIT0600060085Ref VIT0500150150Ref VIT0500060150Ref VIT0600150085Ref VIT0500060085Ref VIT0600060150Ref VIT0700040085Ref VIT0500150085Ref VIT0500040150Ref VIT0400150085Ref VIT0700060150Ref VIT0200120150Ref VIT0300040150Ref VIT0300060085Ref VIT0400060085Ref VIT0400120085

by eucatech AG

Identity

Trade Name: VITUS EUDAMED
Device Name: VITUS Paclitaxel Coated PTA Catheter EUDAMED
Model / Reference: VIT0300150085 EUDAMED
VIT0400040150 EUDAMED
VIT0250040150 EUDAMED
VIT0250150150 EUDAMED
VIT0200080150 EUDAMED
VIT0250120085 EUDAMED
VIT0400080085 EUDAMED
VIT0250120150 EUDAMED
VIT0700150150 EUDAMED
VIT0400040085 EUDAMED
VIT0600040085 EUDAMED
VIT0300080150 EUDAMED
VIT0300080085 EUDAMED
VIT0400060150 EUDAMED
VIT0500080150 EUDAMED
VIT0250080085 EUDAMED
VIT0700080150 EUDAMED
VIT0600150150 EUDAMED
VIT0200150085 EUDAMED
VIT0600080085 EUDAMED
VIT0400120150 EUDAMED
VIT0500120085 EUDAMED
VIT0250150085 EUDAMED
VIT0200080085 EUDAMED
VIT0700080085 EUDAMED
VIT0200120085 EUDAMED
VIT0600080150 EUDAMED
VIT0600060085 EUDAMED
VIT0500150150 EUDAMED
VIT0500060150 EUDAMED
VIT0600150085 EUDAMED
VIT0500060085 EUDAMED
VIT0600060150 EUDAMED
VIT0700040085 EUDAMED
VIT0500150085 EUDAMED
VIT0500040150 EUDAMED
VIT0400150085 EUDAMED
VIT0700060150 EUDAMED
VIT0200120150 EUDAMED
VIT0300040150 EUDAMED
VIT0300060085 EUDAMED
VIT0400060085 EUDAMED
VIT0400120085 EUDAMED

Identifiers

Primary DI / UDI-DI: 04251895630490 EUDAMED
04251895630858 EUDAMED
04251895630759 EUDAMED
04251895630797 EUDAMED
04251895630728 EUDAMED
04251895630438 EUDAMED
04251895630520 EUDAMED
04251895630780 EUDAMED
04251895631046 EUDAMED
04251895630506 EUDAMED
04251895630605 EUDAMED
04251895630827 EUDAMED
04251895630476 EUDAMED
04251895630865 EUDAMED
04251895630926 EUDAMED
04251895630421 EUDAMED
04251895631022 EUDAMED
04251895630995 EUDAMED
04251895630391 EUDAMED
04251895630629 EUDAMED
04251895630889 EUDAMED
04251895630582 EUDAMED
04251895630445 EUDAMED
04251895630377 EUDAMED
04251895630674 EUDAMED
04251895630384 EUDAMED
04251895630971 EUDAMED
04251895630612 EUDAMED
04251895630940 EUDAMED
04251895630919 EUDAMED
04251895630643 EUDAMED
04251895630568 EUDAMED
04251895630964 EUDAMED
04251895630650 EUDAMED
04251895630599 EUDAMED
04251895630902 EUDAMED
04251895630544 EUDAMED
04251895631015 EUDAMED
04251895630735 EUDAMED
04251895630803 EUDAMED
04251895630469 EUDAMED
04251895630513 EUDAMED
04251895630537 EUDAMED
Basic UDI-DI: B-04251895630490 EUDAMED
B-04251895630858 EUDAMED
B-04251895630759 EUDAMED
B-04251895630797 EUDAMED
B-04251895630728 EUDAMED
B-04251895630438 EUDAMED
B-04251895630520 EUDAMED
B-04251895630780 EUDAMED
B-04251895631046 EUDAMED
B-04251895630506 EUDAMED
B-04251895630605 EUDAMED
B-04251895630827 EUDAMED
B-04251895630476 EUDAMED
B-04251895630865 EUDAMED
B-04251895630926 EUDAMED
B-04251895630421 EUDAMED
B-04251895631022 EUDAMED
B-04251895630995 EUDAMED
B-04251895630391 EUDAMED
B-04251895630629 EUDAMED
B-04251895630889 EUDAMED
B-04251895630582 EUDAMED
B-04251895630445 EUDAMED
B-04251895630377 EUDAMED
B-04251895630674 EUDAMED
B-04251895630384 EUDAMED
B-04251895630971 EUDAMED
B-04251895630612 EUDAMED
B-04251895630940 EUDAMED
B-04251895630919 EUDAMED
B-04251895630643 EUDAMED
B-04251895630568 EUDAMED
B-04251895630964 EUDAMED
B-04251895630650 EUDAMED
B-04251895630599 EUDAMED
B-04251895630902 EUDAMED
B-04251895630544 EUDAMED
B-04251895631015 EUDAMED
B-04251895630735 EUDAMED
B-04251895630803 EUDAMED
B-04251895630469 EUDAMED
B-04251895630513 EUDAMED
B-04251895630537 EUDAMED
EMDN Code: C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED

Classification

Device Class: Class III EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

Yes

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

Yes

EUDAMED

Category: Peripheral angioplasty balloon catheter, basic

Vitus by eucatech AG — Class III — 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
Advocate™ — Merit Medical Systems, Inc. · Class II
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-04251895630490	Class III	Active

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Manufacturer

Manufacturer: eucatech AG
EUDAMED SRN: DE-MF-000005541

Sources (43)

EUDAMED ed1804aa-61de-4fb8-9d85-6bac274aa0f4 61 fields · synced Sep 17, 2026
EUDAMED 6a816b6a-4091-43b8-8b0c-6b8e8da5a468 61 fields · synced May 16, 2026
EUDAMED 9144bd98-ac40-4ec7-b0d4-b207cb2f6988 61 fields · synced May 16, 2026
EUDAMED 7cdb78c0-b12f-471e-845e-366bea578b8f 61 fields · synced May 16, 2026
EUDAMED ff751f45-9d1c-4d56-b86a-bb1503f418d3 61 fields · synced May 16, 2026
EUDAMED 8ec109c8-3fe8-44f3-bdbc-f69ed6d0daf7 61 fields · synced May 16, 2026
EUDAMED c797716c-6447-493b-8530-faff27916b5a 61 fields · synced May 16, 2026
EUDAMED c77e6cbc-5f3b-492b-90ec-f76974be45e8 61 fields · synced May 16, 2026
EUDAMED fedeeff6-ede8-47e6-8bd5-6373f44f0048 61 fields · synced May 16, 2026
EUDAMED 43322e8f-5f26-4121-8bd9-1fb3b6ab2410 61 fields · synced May 17, 2026
EUDAMED 6f1b56f9-0176-4d95-b07a-cbfb4cfe1c8e 61 fields · synced May 17, 2026
EUDAMED 201287ab-9e1b-4d94-afef-5ed37011850b 61 fields · synced May 17, 2026
EUDAMED 47ae6529-284a-4a49-875d-3946ddd36c62 61 fields · synced May 17, 2026
EUDAMED 2f6a59e1-06af-4f87-934e-fce463e36ec1 61 fields · synced May 17, 2026
EUDAMED f9ae623e-b893-4b3c-aaff-f9b2aa33fd7a 61 fields · synced May 17, 2026
EUDAMED 66f3abdc-1bf9-4baf-964d-f2dc84f11547 61 fields · synced May 17, 2026
EUDAMED e03be10f-1262-4069-867d-30082a5518ee 61 fields · synced May 17, 2026
EUDAMED 19d29026-caf0-4c5b-9750-88a2e00d0052 61 fields · synced May 17, 2026
EUDAMED c599c409-c724-4f76-aee4-bd17b425d030 61 fields · synced May 17, 2026
EUDAMED baaa43f5-194e-451c-9513-800b9d94a0ac 61 fields · synced May 17, 2026
EUDAMED 0186611b-68a6-403b-847d-93f0163f466f 61 fields · synced May 17, 2026
EUDAMED 0242993d-80c0-41cb-83d6-0ee48bb6b39b 61 fields · synced May 17, 2026
EUDAMED dbb1899f-8a4e-4ccd-b36a-f11e310e8a59 61 fields · synced May 17, 2026
EUDAMED 956c7b49-1cbc-4e3b-b194-5c3b0c8e129a 61 fields · synced May 17, 2026
EUDAMED 95a1ba0c-0823-4c4c-bc35-277aedeeadd4 61 fields · synced May 18, 2026
EUDAMED 2bd08064-3639-4656-b19f-cfab88d8d8f8 61 fields · synced May 18, 2026
EUDAMED 0c35ad0a-643f-4446-a9a1-1705bc3c917b 61 fields · synced May 18, 2026
EUDAMED 74c8e616-6cc3-4a95-9890-3395dd4d6c37 61 fields · synced May 18, 2026
EUDAMED 62550286-be64-42d4-923f-b2e84c35b957 61 fields · synced May 18, 2026
EUDAMED 85e70e7d-e4da-4fe0-80e2-26f24c37f662 61 fields · synced May 18, 2026
EUDAMED a5f6e595-14e1-445f-87f9-7ef8f48d1fca 61 fields · synced May 18, 2026
EUDAMED 590f67ed-1384-431f-813c-b624b84111a6 61 fields · synced May 18, 2026
EUDAMED 8350d86b-a111-4c0e-87e5-df1c3f56e3e1 61 fields · synced May 18, 2026
EUDAMED d66dceb9-3b19-4001-8c8f-add476641207 61 fields · synced May 18, 2026
EUDAMED 86e36009-0071-4c48-a754-731a8aca8753 61 fields · synced May 18, 2026
EUDAMED 857fdec8-d745-4871-9eb7-1abab0e37fb7 61 fields · synced May 19, 2026
EUDAMED e753e96c-5666-44f5-adc3-57855de25a9e 61 fields · synced May 19, 2026
EUDAMED ffe8a1fe-4483-4342-aba4-acabfca6cc5c 61 fields · synced May 19, 2026
EUDAMED ac74c1ff-46fb-4777-af7e-9a9b2cb3bcb5 61 fields · synced May 19, 2026
EUDAMED 64c5ca80-be78-4ba4-a268-eebac1aa79b6 61 fields · synced May 19, 2026
EUDAMED 53f16f50-617c-4664-be09-4d8ec914c381 61 fields · synced May 19, 2026
EUDAMED 607abf7b-7692-4580-9aac-57c590aa5569 61 fields · synced May 19, 2026
EUDAMED e7bab40f-2fe1-4152-bcd3-ae7fde17baf0 61 fields · synced May 19, 2026