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A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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BT 3600 S/I

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622964766
Basic UDI-DI: 0803362296476UM
Reference: BT 3600 S/I
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details

BT 3600

IVD Class AIVDR 2017/746No longer on the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622964759
Basic UDI-DI: 0803362296475UK
Reference: BT 3600
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details

BT 1500i

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622964674
Basic UDI-DI: 0803362296467UL
Reference: BT 1500i
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details

08033622964582

BT 4500V

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622964582
Basic UDI-DI: 0803362296483UJ
Reference: BT 4500V-A-A
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details

BT 4500S S/ISE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622964445
Basic UDI-DI: 0803362296444U8
Reference: BT 4500S S/I
EMDN: W0201010102
EMDN description: CHEMISTRY ANALYSERS - MODERATE ROUTINE (Random access without ISE mode test/h > 400 and <= 800)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details

BT15i

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622964186
Basic UDI-DI: 0803362296418U7
Reference: BT15i
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Türkiye
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details

CB250-B-G

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622964148
Basic UDI-DI: 0803362296414TX
Reference: CB250-B-G
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details

BT 1500

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622963608
Basic UDI-DI: 0803362296360TZ
Reference: BT 1500-A-A
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details

AUTOLYSER

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622963592
Basic UDI-DI: 0803362296359UG
Reference: AUTOLYSER
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Austria
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details

BT 1500

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622963585
Basic UDI-DI: 0803362296358UE
Reference: BT 1500
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details

08033622963523

BT35i

IVD Class AIVDR 2017/746Not intended for EU marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622963523
Basic UDI-DI: 0803362296394UJ
Reference: BT35i
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: -
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details

08033622963363

BT 3500

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622963363
Basic UDI-DI: 0803362296336U4
Reference: BT 3500
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details

BT 3000 PLUS SENZA ISE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622963264
Basic UDI-DI: 0803362296326TZ
Reference: BT 3000 P S/I
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details

BT 3500 S/ISE-TS

BT 3500 S/ISE

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622963448
Basic UDI-DI: 0803362296435U7
Reference: BT 3500 S/I-E
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details

08033622963219

BT 3000 PLUS

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Biotecnica Instruments S.r.l.
Manufacturer SRN: IT-MF-000008115
UDI-DI: 08033622963219
Basic UDI-DI: 0803362296321TP
Reference: BT 3000 PLUS
EMDN: W0201010101
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)
First on market country: Italy
Authorised representative: -
Last updated: 16.07.2026 03:29

Manufacturer products View details

VersaCell X3 Solution

IVDR_27_LLB_DUB-C_A_INST_VersaCell X3

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414595177
Basic UDI-DI: 0405686901993WQ
Reference: 10793839
EMDN: W0201010180
EMDN description: CHEMISTRY ANALYSERS - HARDWARE ACCESSORIES
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:34

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension® EXL™ with LM Integrated Chemistry System

IVDR_67_GLA_DUB-C_A_INST_EXL 200 w/LM integrated chem system

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00630414014128
Basic UDI-DI: 0405686902000UH
Reference: 10475506
EMDN: W0201010105
EMDN description: CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h <= 400)
First on market country: Belgium
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:32

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista Barcode Labels

IVDR_67_GLA_DUB-C_A_INST_Barcode Labels

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768024719
Basic UDI-DI: 0405686901009UU
Reference: 10464353
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:30

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista® Empty Vials Kit

IVDR_67_GLA_DUB-C_A_INST_Empty Vials Kit

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016295
Basic UDI-DI: 0405686901014UM
Reference: 10445213
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

Dimension Vista Cuvettes (CUV)

IVDR_67_GLA_DUB-C_A_INST_CUV

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016271
Basic UDI-DI: 0405686901010UD
Reference: 10445211
EMDN: W0201010185
EMDN description: CHEMISTRY ANALYSERS - CONSUMABLES
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details