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IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06973262861402
Basic UDI-DI: 6973262863020104*******AX
Reference: 3020104
EMDN: W0202010201
EMDN description: AUTOMATED 3 PART HEMATOLOGY ANALYSERS
First on market country: Türkiye
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:27

Manufacturer products Authorised representative products Authorised representative actors View details

06941967227038

C-Reactive Protein Kit (Immunoturbidimetric Method)

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967227038
Basic UDI-DI: 69732628630110*********XH
Reference: 3011001
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224556

Check-P

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224556
Basic UDI-DI: 6973262860006525
Reference: 01.09.31.01.Q.32
EMDN: W01021521
EMDN description: MULTICOMPONENT IMMUNOCHEMISTRY CONTROLS
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224532

Cal-P

IVD Class CIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224532
Basic UDI-DI: 6973262860006423
Reference: 01.09.31.00.01.03
EMDN: W0102152203
EMDN description: SPECIFIC PROTEIN STANDARDS AND CALIBRATORS
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224501

IVD Class AIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224501
Basic UDI-DI: 69732628600060ZQ
Reference: 01.09.31.03.01.03
EMDN: W0599
EMDN description: IVD GENERAL USE CONSUMABLE DEVICES - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224471

SR-I

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224471
Basic UDI-DI: 69732628600063ZW
Reference: 01.09.30.01.01.04
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967224440

CR-I

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967224440
Basic UDI-DI: 69732628600062ZU
Reference: 01.09.30.00.Z.25
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

Hematology Analyzer

Z50

IVD Class BIVDR 2017/746On the marketInstrument

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967213123
Basic UDI-DI: 69732628630301*********ZR
Reference: 3030102
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Netherlands
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967200932

EXZ 6000

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967200932
Basic UDI-DI: 69732628600061ZS
Reference: 02-13-01-0004-00
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

06941967200895

EXZ 6000Pro, EXZ 6010Pro, EXZ 6020Pro

IVD Class BIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Zybio Inc.
Manufacturer SRN: CN-MF-000003349
UDI-DI: 06941967200895
Basic UDI-DI: 6973262860003924
Reference: 02-13-04-0010-00
EMDN: W0202010101
EMDN description: AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
First on market country: Germany
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 14:24

Manufacturer products Authorised representative products Authorised representative actors View details

PALL ORO gas line filter

Class IIaNot specifiedOn the market

Manufacturer: Pall International SARL
Manufacturer SRN: CH-MF-000023177
UDI-DI: 05034480000446
Basic UDI-DI: 5034480GSLF05NINVFE
Reference: ORO1H
EMDN: -
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 13:08

Manufacturer products Authorised representative products Authorised representative actors View details

PALL insufflator gas line filter

Class IIaNot specifiedOn the marketSingle useSterile

Manufacturer: Pall International SARL
Manufacturer SRN: CH-MF-000023177
UDI-DI: 05034480001252
Basic UDI-DI: 5034480GSLF05NINVFE
Reference: IGF1
EMDN: -
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 13:08

Manufacturer products Authorised representative products Authorised representative actors View details

PALL Nanodyne ELD filter

Class IIaNot specifiedOn the market

Manufacturer: Pall International SARL
Manufacturer SRN: CH-MF-000023177
UDI-DI: 05034480001306
Basic UDI-DI: 5034480IVFC05NINVE8
Reference: ELD96LLCE
EMDN: -
EMDN description: WITHDRAWL AND ADMINISTRATION FILTERS (0.2-1.2 MICRONS)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 13:08

Manufacturer products Authorised representative products Authorised representative actors View details

PALL Nanodyne ELD filter

Class IIaNot specifiedOn the marketSingle useSterile

Manufacturer: Pall International SARL
Manufacturer SRN: CH-MF-000023177
UDI-DI: 05034480001313
Basic UDI-DI: 5034480IVFC05NINVE8
Reference: ELD96LYLE
EMDN: -
EMDN description: WITHDRAWL AND ADMINISTRATION FILTERS (0.2-1.2 MICRONS)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 13:08

Manufacturer products Authorised representative products Authorised representative actors View details

Pall Insufflator Gas Line Filter

Class IIaNot specifiedOn the marketSingle useSterile

Manufacturer: Pall International SARL
Manufacturer SRN: CH-MF-000023177
UDI-DI: 05034480101099
Basic UDI-DI: 5034480GSLF05NINVFE
Reference: IGF1L
EMDN: -
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 13:08

Manufacturer products Authorised representative products Authorised representative actors View details

Pall Insufflator Gas Line Filter

Class IIaNot specifiedOn the marketSingle useSterile

Manufacturer: Pall International SARL
Manufacturer SRN: CH-MF-000023177
UDI-DI: 05034480101532
Basic UDI-DI: 5034480GSLF05NINVFE
Reference: IGF1M
EMDN: -
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 13:08

Manufacturer products Authorised representative products Authorised representative actors View details

Pall Lipipor™NEO Filter

Class IIaNot specifiedOn the market

Manufacturer: Pall International SARL
Manufacturer SRN: CH-MF-000023177
UDI-DI: 05034480104366
Basic UDI-DI: 5034480IVFL05NINVJZ
Reference: NLF1E
EMDN: -
EMDN description: WITHDRAWL AND ADMINISTRATION FILTERS (0.2-1.2 MICRONS)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 13:08

Manufacturer products Authorised representative products Authorised representative actors View details

Pall Supor™ AEF Filter

Class IIaNot specifiedOn the marketSingle useSterile

Manufacturer: Pall International SARL
Manufacturer SRN: CH-MF-000023177
UDI-DI: 05034480104373
Basic UDI-DI: 5034480IVFC05NINVE8
Reference: AEF1E
EMDN: -
EMDN description: WITHDRAWL AND ADMINISTRATION FILTERS (0.2-1.2 MICRONS)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 13:08

Manufacturer products Authorised representative products Authorised representative actors View details

Pall Insufflator Gas Line Filter

Class IIaNot specifiedOn the marketSingle useSterile

Manufacturer: Pall International SARL
Manufacturer SRN: CH-MF-000023177
UDI-DI: 05034480105462
Basic UDI-DI: 5034480GSLF05NINVFE
Reference: IGF1E
EMDN: -
EMDN description: ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 13:08

Manufacturer products Authorised representative products Authorised representative actors View details

Pall Lipipor™ TNA Filter

Class IIaNot specifiedOn the marketSingle useSterile

Manufacturer: Pall International SARL
Manufacturer SRN: CH-MF-000023177
UDI-DI: 05034480300843
Basic UDI-DI: 5034480IVFL05NINVJZ
Reference: TNA2E
EMDN: -
EMDN description: WITHDRAWL AND ADMINISTRATION FILTERS (0.2-1.2 MICRONS)
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 02.07.2026 13:08

Manufacturer products Authorised representative products Authorised representative actors View details