IVDR Class B medical devices in EUDAMED

Browse IVDR Class B medical devices registered in EUDAMED. Each result links to the manufacturer, certificates, and identifiers.

Regulation & class

MDRMedical Device Regulation — (EU) 2017/745

Class IClass IIaClass IIbClass III

IVDRIn Vitro Diagnostic Regulation — (EU) 2017/746

IVDR Class AIVDR Class BIVDR Class CIVDR Class D

MDD (legacy)Medical Device Directive — 93/42/EEC

Class IClass IIaClass IIbClass III

IVDD (legacy)In Vitro Diagnostic Directive — 98/79/EC

IVDD — GeneralIVDD — Annex II List AIVDD — Annex II List BIVDD — Self-testing

AIMDD (legacy)Active Implantable Directive — 90/385/EEC

Manufacturer country

AustriaBelgiumBulgariaCroatiaCyprusCzechiaDenmarkEstoniaFinlandFranceGermanyGreeceHungaryIcelandIrelandItalyLatviaLiechtensteinLithuaniaLuxembourgMaltaNetherlandsNorwayPolandPortugalRomaniaSlovakiaSloveniaSpainSwedenSwitzerlandUnited Kingdom

Market country

Available in

Issuing entity

GS1HIBCCEUDAMEDICCBBAIFA

Device characteristics

SterileSingle useContains latexDirect markingSterilizationCMR substanceReprocessed single-useAnnex XVI applicableOEM applicableImplantableReagent (IVD)

EMDN status

Last updated

AfterBefore

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1001 IVDR Class B medical devices in EUDAMED

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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Regulation & class

MDRMedical Device Regulation — (EU) 2017/745

Class IClass IIaClass IIbClass III

IVDRIn Vitro Diagnostic Regulation — (EU) 2017/746

IVDR Class AIVDR Class BIVDR Class CIVDR Class D

MDD (legacy)Medical Device Directive — 93/42/EEC

Class IClass IIaClass IIbClass III

IVDD (legacy)In Vitro Diagnostic Directive — 98/79/EC

IVDD — GeneralIVDD — Annex II List AIVDD — Annex II List BIVDD — Self-testing

AIMDD (legacy)Active Implantable Directive — 90/385/EEC

Manufacturer country

Market country

Available in

Issuing entity

GS1HIBCCEUDAMEDICCBBAIFA

Device characteristics

SterileSingle useContains latexDirect markingSterilizationCMR substanceReprocessed single-useAnnex XVI applicableOEM applicableImplantableReagent (IVD)

EMDN status

Last updated

AfterBefore

1 2 3 4 5

Results Found

1,001 devices match your query

1 / 51

1107101L

1107101L

On the market

Risk category

IVDR Class B

Basic UDI-DI

8431673TLTF402R

Organization name

Spinreact S.A.U.

1107101

1107101

On the market

Risk category

IVDR Class B

Basic UDI-DI

8431673TLTF402R

Organization name

Spinreact S.A.U.

IMMULITE 2000 Date Palm Specific Allergen

10386091

On the market

Risk category

IVDR Class B

Basic UDI-DI

0405686900363VA

Organization name

Siemens Healthcare Diagnostics Products Ltd.

IMMULITE 2000 Salt grass Specific Allergen

10385915

On the market

Risk category

IVDR Class B

Basic UDI-DI

0405686900637VQ

Organization name

Siemens Healthcare Diagnostics Products Ltd.

IMMULITE 2000 Inhalent Panel 1 Specific Allergen

10385968

On the market

Risk category

IVDR Class B

Basic UDI-DI

0405686900459VQ

Organization name

Siemens Healthcare Diagnostics Products Ltd.

IMMULITE 2000 Ispaghula Specific Allergen

10385988

On the market

Risk category

IVDR Class B

Basic UDI-DI

0405686900473VJ

Organization name

Siemens Healthcare Diagnostics Products Ltd.

IMMULITE 2000 Foxtail Millet Specific Allergen

10385838

On the market

Risk category

IVDR Class B

Basic UDI-DI

0405686900413UY

Organization name

Siemens Healthcare Diagnostics Products Ltd.

IMMULITE 2000 Plaice Specific Allergen

10385747

On the market

Risk category

IVDR Class B

Basic UDI-DI

0405686900591VR

Organization name

Siemens Healthcare Diagnostics Products Ltd.

IMMULITE 2000 Allergy Specific IgG

10380880

On the market

Risk category

IVDR Class B

Basic UDI-DI

0405686901366VP

Organization name

Siemens Healthcare Diagnostics Products Ltd.

1-DOA-1124 028

1-DOA-1124 028

On the market

Risk category

IVDR Class B

Basic UDI-DI

59026439BRTDOA1124028TD

Organization name

BioMaxima Spółka Akcyjna

1-337-K010

1-337-K010

On the market

Risk category

IVDR Class B

Basic UDI-DI

59026439BRT337JT

Organization name

BioMaxima Spółka Akcyjna

E110117 (B)

E110117 (B)

On the market

Risk category

IVDR Class B

Basic UDI-DI

59026439BASTAMCPN

Organization name

BioMaxima Spółka Akcyjna

AZTREONAM

0009B30

On the market

Risk category

IVDR Class B

Basic UDI-DI

59026439BBMATMJ5

Organization name

BioMaxima Spółka Akcyjna

1415-1030

On the market

Risk category

IVDR Class B

Basic UDI-DI

5204309000039P5

Organization name

Medicon Hellas SA

E110108 (B)

E110108 (B)

On the market

Risk category

IVDR Class B

Basic UDI-DI

59026439BASTMECQS

Organization name

BioMaxima Spółka Akcyjna

3000-2269

3000-2269

On the market

Risk category

IVDR Class B

Basic UDI-DI

842695003695173

Organization name

Biokit S.A.

E111412 (K)

E111412 (K)

On the market

Risk category

IVDR Class B

Basic UDI-DI

59026439BASTDOLP

Organization name

BioMaxima Spółka Akcyjna

E111412 (W)

E111412 (W)

On the market

Risk category

IVDR Class B

Basic UDI-DI

59026439BASTDOLP

Organization name

BioMaxima Spółka Akcyjna

E191823 (K)

E191823 (K)

On the market

Risk category

IVDR Class B

Basic UDI-DI

59026439BASTDOLP

Organization name

BioMaxima Spółka Akcyjna

E111412 (B)

E111412 (B)

On the market

Risk category

IVDR Class B

Basic UDI-DI

59026439BASTDOLP

Organization name

BioMaxima Spółka Akcyjna