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Terumo Europe N.V.

Active in EUDAMED

Belgiumfrom SRN EUDAMED FDA SRN BE-MF-000001434 FEI 3001570557

Devices
359
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

EU certificates

9 of 9 in force.

See certificates

Market reach

European Union
EUDAMED actor, 9 certificates
United States
FDA FEI

What Terumo Europe N.V. makes

Terumo Europe N.V. makes medical devices such as the Ultimaster Tansei.

The company's portfolio includes devices classified as Class II, Class IIa, and Class III, and is listed in registries such as eudamed and fda_510k, with the company based in Belgium.

AI-generated from registry data, 5 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue359

Newest first, rows 1-50 of 359

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  • Outlook - Angiographic catheter Ref RQ-4AP5581M

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Ultimaster Nagomi Ref DE-RS3038ASM

    Expiring Regimes: CE MDR Registry: EUDAMED Class:III

  • Ultimaster Tansei Ref DE-RQ3533KSM

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Ultimaster Tansei Ref DE-RQ3033KSM

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Ultimaster Tansei Ref DE-RQ2738KSM

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • RADIFOCUS Optitorque Ref RH-5BPJR00M

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • RADIFOCUS Guide Wire M Non-Vascular Ref NV-GS35153M

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • RADIFOCUS Guide Wire M Non-Vascular Ref NV-GA35183M

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • RADIFOCUS Guide Wire M Non-Vascular Ref NV-PS35263M

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • RADIFOCUS Optitorque Ref RH-6CR4500M

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • RADIFOCUS Guide Wire M Ref RF-GS18263M

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Ultimaster Nagomi Ref DE-RS2721ASM

    Expiring Regimes: CE MDR Registry: EUDAMED Class:III

  • RADIFOCUS Optitorque Ref RH-5SP0061M

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • RADIFOCUS Optitorque Ref RH-5BPJL00M

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • RADIFOCUS Guide Wire M Non-Vascular Ref NV-PS18453M

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • RADIFOCUS Guide Wire M Non-Vascular Ref NV-GA18153M

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • RADIFOCUS Optitorque Ref RH-5CL4001M

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Neolus Needle Ref NN-2325R

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Ultimaster Nagomi Ref DE-RS2550ASM

    Expiring Regimes: CE MDR Registry: EUDAMED Class:III

  • RADIFOCUS Optitorque Ref RH-AB54108M

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Ultimaster Nagomi Ref DE-RS2709ASM

    Expiring Regimes: CE MDR Registry: EUDAMED Class:III

  • RADIFOCUS Guide Wire M Ref RF-GA32183M

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • RADIFOCUS Angiographic Catheter Ref RF-DB2500GM

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • RADIFOCUS Glidecath Catheter Ref RF-XD4510GM

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • RADIFOCUS Guide Wire M Non-Vascular Ref NV-GS35453M

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • RADIFOCUS Optitorque – Angiographic catheter Ref RH-6JR6000M

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • RADIFOCUS Optitorque Ref RH-AED510GM

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Ultimaster Nagomi Ref DE-RS3528ASM

    Expiring Regimes: CE MDR Registry: EUDAMED Class:III

  • Ultimaster Nagomi Ref DE-RS2050ASM

    Expiring Regimes: CE MDR Registry: EUDAMED Class:III

  • Ultimaster Nagomi Ref DE-RS3028ASM

    Expiring Regimes: CE MDR Registry: EUDAMED Class:III

  • Ultimaster Nagomi Ref DE-RS2515ASM

    Expiring Regimes: CE MDR Registry: EUDAMED Class:III

  • Ultimaster Nagomi Ref DE-RS4044ASM

    Expiring Regimes: CE MDR Registry: EUDAMED Class:III

  • Neolus Needle Ref NN-2325R04T

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • RADIFOCUS Optitorque Ref RH-BH94102M

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • RADIFOCUS Optitorque Ref RH-AB5510GM

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • RADIFOCUS Optitorque Ref RH-5BLK410M

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • RADIFOCUS Angiographic Catheter Ref RF-DA15008M

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Ultimaster Nagomi Ref DE-RS4009ASM

    Expiring Regimes: CE MDR Registry: EUDAMED Class:III

  • RADIFOCUS Optitorque Ref RH-5AR3000M

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • RADIFOCUS Guide Wire M Non-Vascular Ref NV-GS32403M

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • K-Pack II Needle Ref KN-2713RBKTI

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Neolus Needle Ref NN-2525R04T

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • RADIFOCUS Optitorque Ref RH-AB55108M

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Outlook - Angiographic catheter Ref RQ-4AL3000M

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • RADIFOCUS Glidecath Catheter Ref RF-YE15110M

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • RADIFOCUS Angiographic Catheter Ref RF-EB15010M

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • RADIFOCUS Optitorque Ref RH-5BPIN00M

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • RADIFOCUS Optitorque Ref RH-5AL2000M

    Active Regimes: CE MDD Registry: EUDAMED Class:III

  • Ultimaster Nagomi Ref DE-RS4550ASM

    Expiring Regimes: CE MDR Registry: EUDAMED Class:III

  • RADIFOCUS Guide Wire M Non-Vascular Ref NV-GA25153M

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

Rows 1-50 of 359

Showing 1-50 of 359

Company details

EUDAMED SRN
BE-MF-000001434
SRN (system / procedure pack)
BE-PR-000001431
FDA FEI number
3001570557
EU VAT number
BE 0408 270 327
EUDAMED status
Active
EUDAMED registered name
TERUMO EUROPE N.V.
Registered address
40, Interleuvenlaan, 3001, Leuven, Belgium
Phone
+3216381211
PRRC contact
Koen Verhaert(public in EUDAMED)

EUDAMED certificates9

9 certificates9 valid, 0 expiredMDR 9next expiry 30 Nov 2026

EUDAMED certificates (9)

TÜV Rheinland LGA Products GmbH 0197 6 certificates

  • IZ 1594584-5 Active

    Technical documentation EU MDR

    Issued
    16 Oct 2025
    Expires
    15 Oct 2030
  • IZ 1594584-3 Active

    Technical documentation EU MDR

    Issued
    23 Aug 2025
    Expires
    22 Aug 2030
  • IZ 1594584-4 Active

    Technical documentation EU MDR

    Issued
    17 Jun 2025
    Expires
    16 Jun 2030
  • IZ 1594584-2 Active

    Technical documentation EU MDR

    Issued
    9 May 2025
    Expires
    8 May 2030
  • IZ 1594584-1 Active

    Technical documentation EU MDR

    Issued
    14 Apr 2025
    Expires
    13 Apr 2030
  • HZ 1594584-1 Expiring Supplemented Expires in 61 days

    Quality management system EU MDR

    Issued
    23 Aug 2025
    Expires
    31 Dec 2026
    Reason
    Other

DNV MEDCERT GmbH 0482 3 certificates

  • 13090GB450250128 Active

    Technical documentation EU MDR

    Issued
    28 Jan 2025
    Expires
    27 Jan 2030
  • 20232GB450221124 Expiring Expires in 30 days

    Technical documentation EU MDR

    Issued
    24 Nov 2022
    Expires
    30 Nov 2026
  • 3479GB448221124 Expiring Expires in 30 days

    Quality management system EU MDR

    Issued
    24 Nov 2022
    Expires
    30 Nov 2026

Frequently asked questions

How many devices does Terumo Europe N.V. have in the registry?

The registry currently lists 359 devices for Terumo Europe N.V.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Terumo Europe N.V.'s devices?

Among its 50 most recently registered devices, Terumo Europe N.V. has devices listed in EUDAMED (50 devices).

What risk classes do Terumo Europe N.V.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Terumo Europe N.V.'s devices are Class IIa and Class III. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Terumo Europe N.V.?

EUDAMED lists 9 certificates for Terumo Europe N.V. (technical documentation; quality management system) under MDR. 8 are recorded with the status issued. The most recent was issued on 16 Oct 2025.

What are the newest devices from Terumo Europe N.V. in the registry?

The most recently registered devices listed for Terumo Europe N.V. include Outlook - Angiographic catheter, Ultimaster Nagomi, Ultimaster Tansei and RADIFOCUS Optitorque.

Generated automatically from registry data and not verified by a human reviewer.