Jade PTA

EUDAMED

Class IIa (EU MDR)

Ref 545-120-41Model Ø 4.5 x 120 mmRef 540-120-41Model Ø 4.0 x 120 mmRef 535-240-41Model Ø 3.5 x 240mmRef 560-080-41Model Ø 6.0 x 80 mmRef 560-020-41Model Ø 6.0 x 20 mmRef 540-240-41Model Ø 4.0 x 240mmRef 550-020-41Model Ø 5.0 x 20 mmRef 550-180-41Model Ø 5.0 x 180mmRef 525-080-41Model Ø 2.5 x 80 mmRef 540-120-41RModel Ø 4.0 x 120mmRef 515-180-41Model Ø 1.5 x 180mmRef 530-040-41Model Ø 3.0 x 40 mmRef 530-180-41Model Ø 3.0 x 180mmRef 515-240-41Model Ø 1.5 x 240mmRef 515-080-41Model Ø 1.5 x 80 mmRef 535-080-41Model Ø 3.5 x 80 mmRef 555-120-41RModel Ø 5.5 x 120mmRef 545-040-41Model Ø 4.5 x 40 mmRef 525-040-41Model Ø 2.5 x 40 mmRef 530-015-41Model Ø 3.0 x 15 mmRef 520-240-41Model Ø 2.0 x 240mmRef 530-020-41Model Ø 3.0 x 20 mmRef 520-120-41Model Ø 2.0 x 120 mmRef 515-040-41Model Ø 1.5 x 40 mmRef 535-120-41Model Ø 3.5 x 120 mmRef 525-020-41Model Ø 2.5 x 20 mmRef 520-015-41Model Ø 2.0 x 15 mmRef 555-040-41Model Ø 5.5 x 40 mmRef Ø 6.0 x 120mmRef 525-180-41Model Ø 2.5 x 180mmRef 535-180-41Model Ø 3.5 x 180mmRef 550-015-41Model Ø 5.0 x 15 mmRef 520-020-41Model Ø 2.0 x 20 mmRef 540-080-41Model Ø 4.0 x 80 mmRef 540-040-41Model Ø 4.0 x 40 mmRef 545-020-41Model Ø 4.5 x 20 mmRef 545-120-41RModel Ø 4.5 x 120mmRef 550-240-41Model 5.0 x 240mmRef 545-080-41Model Ø 4.5 x 80 mmRef 520-180-41Model Ø 2.0 x 180mm

by OrbusNeich Medical, B.V.

Identity

Trade Name: Jade PTA EUDAMED
Device Name: Jade PTA EUDAMED
Jade PTA Line Extension EUDAMED
Model / Reference: Ø 4.5 x 120 mm EUDAMED
545-120-41 EUDAMED
Ø 4.0 x 120 mm EUDAMED
540-120-41 EUDAMED
Ø 3.5 x 240mm EUDAMED
535-240-41 EUDAMED
Ø 6.0 x 80 mm EUDAMED
560-080-41 EUDAMED
Ø 6.0 x 20 mm EUDAMED
560-020-41 EUDAMED
Ø 4.0 x 240mm EUDAMED
540-240-41 EUDAMED
Ø 5.0 x 20 mm EUDAMED
550-020-41 EUDAMED
Ø 5.0 x 180mm EUDAMED
550-180-41 EUDAMED
Ø 2.5 x 80 mm EUDAMED
525-080-41 EUDAMED
Ø 4.0 x 120mm EUDAMED
540-120-41R EUDAMED
Ø 1.5 x 180mm EUDAMED
515-180-41 EUDAMED
Ø 3.0 x 40 mm EUDAMED
530-040-41 EUDAMED
Ø 3.0 x 180mm EUDAMED
530-180-41 EUDAMED
Ø 1.5 x 240mm EUDAMED
515-240-41 EUDAMED
Ø 1.5 x 80 mm EUDAMED
515-080-41 EUDAMED
Ø 3.5 x 80 mm EUDAMED
535-080-41 EUDAMED
Ø 5.5 x 120mm EUDAMED
555-120-41R EUDAMED
Ø 4.5 x 40 mm EUDAMED
545-040-41 EUDAMED
Ø 2.5 x 40 mm EUDAMED
525-040-41 EUDAMED
Ø 3.0 x 15 mm EUDAMED
530-015-41 EUDAMED
Ø 2.0 x 240mm EUDAMED
520-240-41 EUDAMED
Ø 3.0 x 20 mm EUDAMED
530-020-41 EUDAMED
Ø 2.0 x 120 mm EUDAMED
520-120-41 EUDAMED
Ø 1.5 x 40 mm EUDAMED
515-040-41 EUDAMED
Ø 3.5 x 120 mm EUDAMED
535-120-41 EUDAMED
Ø 2.5 x 20 mm EUDAMED
525-020-41 EUDAMED
Ø 2.0 x 15 mm EUDAMED
520-015-41 EUDAMED
Ø 5.5 x 40 mm EUDAMED
555-040-41 EUDAMED
Ø 6.0 x 120mm EUDAMED
Ø 2.5 x 180mm EUDAMED
525-180-41 EUDAMED
Ø 3.5 x 180mm EUDAMED
535-180-41 EUDAMED
Ø 5.0 x 15 mm EUDAMED
550-015-41 EUDAMED
Ø 2.0 x 20 mm EUDAMED
520-020-41 EUDAMED
Ø 4.0 x 80 mm EUDAMED
540-080-41 EUDAMED
Ø 4.0 x 40 mm EUDAMED
540-040-41 EUDAMED
Ø 4.5 x 20 mm EUDAMED
545-020-41 EUDAMED
Ø 4.5 x 120mm EUDAMED
545-120-41R EUDAMED
5.0 x 240mm EUDAMED
550-240-41 EUDAMED
Ø 4.5 x 80 mm EUDAMED
545-080-41 EUDAMED
Ø 2.0 x 180mm EUDAMED
520-180-41 EUDAMED

Identifiers

Primary DI / UDI-DI: 08717853299162 EUDAMED
08717853299124 EUDAMED
08719244950416 EUDAMED
08717853299292 EUDAMED
08717853299278 EUDAMED
08719244950454 EUDAMED
08717853299186 EUDAMED
08719244950485 EUDAMED
08717853298974 EUDAMED
08719244950430 EUDAMED
08719244950287 EUDAMED
08717853299018 EUDAMED
08719244950379 EUDAMED
08719244950294 EUDAMED
08717853298882 EUDAMED
08717853299063 EUDAMED
08719244950560 EUDAMED
08717853299148 EUDAMED
08717853298967 EUDAMED
08717853298998 EUDAMED
08719244950324 EUDAMED
08717853299001 EUDAMED
08717853298943 EUDAMED
08717853298875 EUDAMED
08717853299070 EUDAMED
08717853298950 EUDAMED
08717853298905 EUDAMED
08717853299230 EUDAMED
08719244950515 EUDAMED
08719244950348 EUDAMED
08719244950409 EUDAMED
08717853299179 EUDAMED
08717853298912 EUDAMED
08717853299117 EUDAMED
08717853299100 EUDAMED
08717853299131 EUDAMED
08719244950553 EUDAMED
08719244950492 EUDAMED
08717853299155 EUDAMED
08719244950317 EUDAMED
Basic UDI-DI: B-08717853299162 EUDAMED
B-08717853299124 EUDAMED
B-08719244950416 EUDAMED
B-08717853299292 EUDAMED
B-08717853299278 EUDAMED
B-08719244950454 EUDAMED
B-08717853299186 EUDAMED
B-08719244950485 EUDAMED
B-08717853298974 EUDAMED
B-08719244950430 EUDAMED
B-08719244950287 EUDAMED
B-08717853299018 EUDAMED
B-08719244950379 EUDAMED
B-08719244950294 EUDAMED
B-08717853298882 EUDAMED
B-08717853299063 EUDAMED
B-08719244950560 EUDAMED
B-08717853299148 EUDAMED
B-08717853298967 EUDAMED
B-08717853298998 EUDAMED
B-08719244950324 EUDAMED
B-08717853299001 EUDAMED
B-08717853298943 EUDAMED
B-08717853298875 EUDAMED
B-08717853299070 EUDAMED
B-08717853298950 EUDAMED
B-08717853298905 EUDAMED
B-08717853299230 EUDAMED
B-08719244950515 EUDAMED
B-08719244950348 EUDAMED
B-08719244950409 EUDAMED
B-08717853299179 EUDAMED
B-08717853298912 EUDAMED
B-08717853299117 EUDAMED
B-08717853299100 EUDAMED
B-08717853299131 EUDAMED
B-08719244950553 EUDAMED
B-08719244950492 EUDAMED
B-08717853299155 EUDAMED
B-08719244950317 EUDAMED
EMDN Code: C010402020101 PTA BALLOON DILATATION CATHETERS EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Denmark EUDAMED
Italy 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

EUDAMED

Category: Peripheral angioplasty balloon catheter, basic

Jade PTA by OrbusNeich Medical, B.V. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral angioplasty balloon catheter, basic.

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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-08717853299162	Class IIa	Active

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Manufacturer

Manufacturer: OrbusNeich Medical, B.V.
EUDAMED SRN: NL-MF-000010907

Sources (40)

EUDAMED ba87f65e-99a2-4767-9e4a-e319a50a6237 61 fields · synced Oct 6, 2026
EUDAMED 0ea4aee9-49a3-48f0-becb-9e4fe41519e5 61 fields · synced May 11, 2026
EUDAMED 62510e67-f454-4d41-b883-99f50022b087 61 fields · synced May 16, 2026
EUDAMED dce78da2-5d44-4c12-a747-adc18aba222a 61 fields · synced May 16, 2026
EUDAMED 477ebb59-5caa-448d-9f26-42a871b4ae75 61 fields · synced May 16, 2026
EUDAMED 0c273f70-607a-460b-8691-d1c69ea9b663 61 fields · synced May 16, 2026
EUDAMED 84821f64-63fb-48ed-8b15-7fc2f7b24c99 61 fields · synced May 16, 2026
EUDAMED 5d7242bd-9abf-4f1b-be3b-1a5f08a7b437 61 fields · synced May 16, 2026
EUDAMED 6b00f4e0-ab40-42dc-b91d-91db38eb9a65 61 fields · synced May 16, 2026
EUDAMED 7ee938e1-cdc6-4e7e-a037-3e253e1b5e23 61 fields · synced May 17, 2026
EUDAMED 64fdd869-ea64-4f61-8779-e064d8372b78 61 fields · synced May 17, 2026
EUDAMED 72bc246d-2ead-45de-b00e-30ecb600665d 61 fields · synced May 17, 2026
EUDAMED 020aa9b5-8a03-40bb-a4a0-aeb20b30f903 61 fields · synced May 17, 2026
EUDAMED 71f50d74-e444-411b-a510-5d095435ea05 61 fields · synced May 17, 2026
EUDAMED a190ea84-c30c-4534-8427-989b95298211 61 fields · synced May 17, 2026
EUDAMED 2ddd28e2-45bc-4b00-91d8-5ff5e78dccd2 61 fields · synced May 17, 2026
EUDAMED 6339beee-3e93-4ca5-8c7a-cf63f1606b56 61 fields · synced May 17, 2026
EUDAMED 9a2e2ad1-cbd8-41d7-9c0a-6b62fa462065 61 fields · synced May 17, 2026
EUDAMED fda41403-290b-4a63-952a-ed297b65c641 61 fields · synced May 17, 2026
EUDAMED c46564ac-da59-4a8a-aadf-67d29b53e9ca 61 fields · synced May 18, 2026
EUDAMED 9d661b4a-74a4-43e2-be5f-8b87f299fb54 61 fields · synced May 18, 2026
EUDAMED 9d712ae1-a252-4fe7-a008-e165d78c1b65 61 fields · synced May 18, 2026
EUDAMED bf96692f-70a6-43f1-96db-b1c55f27c3b6 61 fields · synced May 18, 2026
EUDAMED f3e93bcc-f28b-448a-81f5-c6b398809417 61 fields · synced May 18, 2026
EUDAMED 2fef7582-ef05-4153-b955-e5ebb795e555 61 fields · synced May 18, 2026
EUDAMED a4f400c1-ef20-4aa4-8523-dafc657f6650 61 fields · synced May 18, 2026
EUDAMED a6999ec7-1ddd-4ac2-a5d5-36c8cddf4373 61 fields · synced May 18, 2026
EUDAMED 8fc758f8-aa86-42e2-aa03-657c49472292 61 fields · synced May 18, 2026
EUDAMED 927bd89d-66ef-4706-8304-e5af7ef17be1 61 fields · synced May 18, 2026
EUDAMED 50031d45-6234-432d-b643-335cc7c59b27 61 fields · synced May 18, 2026
EUDAMED 4455fb34-3e9d-4c4a-b12c-78c7fd453690 61 fields · synced May 18, 2026
EUDAMED 9fa0b4d5-97db-47f7-9fc9-d188d45e163a 61 fields · synced May 18, 2026
EUDAMED 6a593c3a-897f-418e-bc84-1eaa04db4c90 61 fields · synced May 18, 2026
EUDAMED ddeed150-f6e3-4b0c-8c0e-624652609a58 61 fields · synced May 18, 2026
EUDAMED 373ec885-0154-4d0b-bc0e-c967271a372d 61 fields · synced Jul 13, 2026
EUDAMED 954d4c9f-1c42-4d3a-aec6-8a51b7b21367 61 fields · synced Jul 17, 2026
EUDAMED 227f2d9c-d33b-495f-b9d4-c080e358c5d5 61 fields · synced Jul 19, 2026
EUDAMED 50a9af33-7a40-4d49-91f9-1812fb973c35 61 fields · synced Jul 21, 2026
EUDAMED 139d4cb4-1105-4706-a79d-dd66dedc959d 61 fields · synced Aug 4, 2026
EUDAMED ee194031-b045-44c2-9438-e8f2a2622ae5 61 fields · synced Sep 17, 2026