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04262522490646

SCK_TASSO

Class IIaMDR 2017/745On the market

Manufacturer: Probatix Health GmbH
Manufacturer SRN: DE-PR-000048885
UDI-DI: 04262522490646
Basic UDI-DI: 426252249SCKTASSO2S
Reference: SCK_TASSO-1S
EMDN: W0501010201
EMDN description: CAPILLARY BLOOD COLLECTION SYSTEMS
First on market country: -
Authorised representative: -
Last updated: 16.07.2026 09:21

Manufacturer products View details

cerascreen® Histamin-Intoleranz Test

Probenahme- und Einsende-Kit Trockenblut

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: Cerascreen GmbH
Manufacturer SRN: DE-MF-000017602
UDI-DI: 04251620707268
Basic UDI-DI: 42516207002JR
Reference: 99010520
EMDN: W0501010201
EMDN description: CAPILLARY BLOOD COLLECTION SYSTEMS
First on market country: Austria
Authorised representative: -
Last updated: 16.07.2026 09:09

Manufacturer products View details

cerascreen® Kombi-Paket Berufliche Leistungsfähigke

Probenahme- und Einsende-Kit Flüssigblut

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: Cerascreen GmbH
Manufacturer SRN: DE-MF-000017602
UDI-DI: 04251620700344
Basic UDI-DI: 42516207001JP
Reference: 99040007
EMDN: W0501010201
EMDN description: CAPILLARY BLOOD COLLECTION SYSTEMS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 09:09

Manufacturer products View details

digene HC2 DNA Collection Device

Class IMDR 2017/745On the marketSingle use

Manufacturer: QIAGEN Sciences LLC
Manufacturer SRN: US-MF-000014502
UDI-DI: 14053228010361
Basic UDI-DI: 4053228MDIGENE0010000016Q
Reference: 619234
EMDN: W05019099
EMDN description: SAMPLES COLLECTION DEVICES - OTHER
First on market country: Germany
Authorised representative: QIAGEN GmbH
Last updated: 16.07.2026 08:36

Manufacturer products Authorised representative products Authorised representative actors View details

Stuhlröhre 101x16,5mm

Stuhlröhren

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: SARSTEDT AG & Co.KG
Manufacturer SRN: DE-MF-000005649
UDI-DI: 04066916059354
Basic UDI-DI: 4038917SARTD02200U5T
Reference: 80.623.058
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 08:16

Manufacturer products View details

Streck

IVD Class ANot specifiedOn the marketDirect markingKitProfessional testingReagentSingle useSterile

Manufacturer: Streck
Manufacturer SRN: US-MF-000013009
UDI-DI: 10844509000836
Basic UDI-DI: 08445090BCTTZ
Reference: 213559
EMDN: W050101010201
EMDN description: BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR
First on market country: -
Authorised representative: MediMark Europe Sarl.
Last updated: 16.07.2026 08:07

Manufacturer products Authorised representative products Authorised representative actors View details

Predicine Bone Marrow Aspirate (BMA) Collection Kit™

PD-SCK30BM-026

IVD Class AIVDR 2017/746On the marketKitSingle use

Manufacturer: Predicine, Inc.
Manufacturer SRN: US-MF-000031888
UDI-DI: 00860013997663
Basic UDI-DI: 08600139976PDSCK30BM026UC
Reference: PD-SCK30BM-026, PD-SCK30BM-027
EMDN: W050101010201
EMDN description: BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:55

Manufacturer products Authorised representative products Authorised representative actors View details

Predicine Urine Collection Kit

PD-SCK30U-003

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: Predicine, Inc.
Manufacturer SRN: US-MF-000031888
UDI-DI: 00860013997618
Basic UDI-DI: 08600139976PDSCK30U003VU
Reference: PD-SCK30U-003
EMDN: W05010203
EMDN description: URINE COLLECTION, CONTAINERS
First on market country: Germany
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:55

Manufacturer products Authorised representative products Authorised representative actors View details

Predicine Blood Collection Kit

PD-SCK30B-007

IVD Class AIVDR 2017/746On the marketDirect markingKitProfessional testingSingle use

Manufacturer: Predicine, Inc.
Manufacturer SRN: US-MF-000031888
UDI-DI: 00860013997601
Basic UDI-DI: 08600139976PDSCK30B007RX
Reference: PD-SCK30B-007
EMDN: W050101010201
EMDN description: BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR
First on market country: Greece
Authorised representative: MDSS GmbH
Last updated: 16.07.2026 06:55

Manufacturer products Authorised representative products Authorised representative actors View details

Advance Dx Blood Collection Card

CMT01-DBL200SQ

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Advance Dx, Inc.
Manufacturer SRN: US-MF-000044758
UDI-DI: 00860013988098
Basic UDI-DI: 08600139880BUDI0012G2
Reference: CMT01-DBL200SQ
EMDN: W0501010199
EMDN description: VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 06:55

Manufacturer products Authorised representative products Authorised representative actors View details

Advance Dx Blood Collection Card

CMT01-MEGA

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Advance Dx, Inc.
Manufacturer SRN: US-MF-000044758
UDI-DI: 00860013988081
Basic UDI-DI: 08600139880BUDI0011FY
Reference: CMT01-MEGA
EMDN: W0501010199
EMDN description: VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 06:55

Manufacturer products Authorised representative products Authorised representative actors View details

Advance Dx Blood Collection Card

CMT01-DBL

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Advance Dx, Inc.
Manufacturer SRN: US-MF-000044758
UDI-DI: 00860013988074
Basic UDI-DI: 08600139880BUDI0010FW
Reference: CMT01-DBL
EMDN: W0501010199
EMDN description: VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 06:55

Manufacturer products Authorised representative products Authorised representative actors View details

Advance Dx Blood Collection Card

CMT01.1

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Advance Dx, Inc.
Manufacturer SRN: US-MF-000044758
UDI-DI: 00860013988067
Basic UDI-DI: 08600139880BUDI0009GD
Reference: CMT01.1
EMDN: W0501010199
EMDN description: VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

Advance Dx Blood Collection Card

WTSSNG500

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Advance Dx, Inc.
Manufacturer SRN: US-MF-000044758
UDI-DI: 00860013988050
Basic UDI-DI: 08600139880BUDI0008GB
Reference: WTSSNG500
EMDN: W0501010199
EMDN description: VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

Advance Dx Blood Collection Card

WTSSNG100

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Advance Dx, Inc.
Manufacturer SRN: US-MF-000044758
UDI-DI: 00860013988043
Basic UDI-DI: 08600139880BUDI0007G9
Reference: WTSSNG100
EMDN: W0501010199
EMDN description: VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

Advance Dx Blood Collection Card

LLS200

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Advance Dx, Inc.
Manufacturer SRN: US-MF-000044758
UDI-DI: 00860013988036
Basic UDI-DI: 08600139880BUDI0006G7
Reference: LLS200
EMDN: W0501010199
EMDN description: VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

Advance Dx Blood Collection Card

WTS500

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Advance Dx, Inc.
Manufacturer SRN: US-MF-000044758
UDI-DI: 00860013988029
Basic UDI-DI: 08600139880BUDI0005G5
Reference: WTS500
EMDN: W0501010199
EMDN description: VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

"Advance Dx Blood Collection Card

CMT01

IVD Class AIVDR 2017/746On the marketSingle use

Manufacturer: Advance Dx, Inc.
Manufacturer SRN: US-MF-000044758
UDI-DI: 00860013988005
Basic UDI-DI: 08600139880BUDI0003FZ
Reference: CMT01
EMDN: W0501010199
EMDN description: VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER
First on market country: Northern Ireland
Authorised representative: Obelis s.a.
Last updated: 16.07.2026 06:54

Manufacturer products Authorised representative products Authorised representative actors View details

AAV5 NAb Test Specimen Collection Kit

GTKIT80001

IVD Class AIVDR 2017/746On the marketKitProfessional testingSingle use

Manufacturer: Precision for Medicine, Inc.
Manufacturer SRN: US-MF-000007346
UDI-DI: 00860006973513
Basic UDI-DI: 0860006973517L
Reference: GTKIT80001
EMDN: W050101010201
EMDN description: BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 16.07.2026 06:51

Manufacturer products Authorised representative products Authorised representative actors View details

QBC Capillary Blood Tube, 100 Test Kit

QBC Capillary Blood Tube

IVD Class AIVDR 2017/746On the marketProfessional testingReagentSingle use

Manufacturer: Drucker Diagnostics
Manufacturer SRN: US-MF-000031517
UDI-DI: 00858092006420
Basic UDI-DI: 0858092006DDCTZ3
Reference: 424241
EMDN: W0501010203
EMDN description: BLOOD COLLECTION, CAPILLARY TUBES
First on market country: Northern Ireland
Authorised representative: Emergo Europe B.V.
Last updated: 16.07.2026 06:42

Manufacturer products Authorised representative products Authorised representative actors View details