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18 device results listed.

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S. pneumoniae Antigen Rapid Test

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: 06936983104975
Basic UDI-DI: 6970277510001DXL
Reference: ISP-N102-10
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: Ireland
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 20:57

Manufacturer products Authorised representative products Authorised representative actors View details

S. pneumoniae Antigen Rapid Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-ISP-R102LV
Basic UDI-DI: B-ISP-R102LV
Reference: ISP-R102
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 27.07.2026 06:37

Manufacturer products Authorised representative products Authorised representative actors View details

Streptococcus pneumoniae Test Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Hangzhou Alltest Biotech.Co.,Ltd.
Manufacturer SRN: CN-MF-000010710
UDI-DI: D-FI-SP-102WP
Basic UDI-DI: B-FI-SP-102WP
Reference: FI-SP-102
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: Austria
Authorised representative: MedNet EC-REP GmbH
Last updated: 20.07.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

Streptococcus pneumoniae Ag Rapid Test Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Dezhou Guoke Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000044128
UDI-DI: D-GKPD105X8
Basic UDI-DI: B-GKPD105X8
Reference: GKPD105
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

SIMPLE Strep pneumo / STICK Strep pneumo

9.107.XXX.YY.ZZZ

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: OPERON, S.A.
Manufacturer SRN: ES-MF-000004790
UDI-DI: D-84295779107XUJJ
Basic UDI-DI: B-84295779107XUJJ
Reference: 9.107.XXX.YY.ZZZ
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: Spain
Authorised representative: -
Last updated: 12.07.2026 10:09

Manufacturer products View details

RapidFor™ S. pneumonia (FIA)

VMPO126UP

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684998271882
Basic UDI-DI: B-08684998271882
Reference: VMPO126
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:21

Manufacturer products View details

RapidFor™ Streptococcus pneumoniae Rapid Test Kit

VMD110

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08684595030486
Basic UDI-DI: B-08684595030486
Reference: VMD110
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 06:14

Manufacturer products View details

S.pneumoniae Rapid Test

GISPNE

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Zhejiang Greylynx Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000032462
UDI-DI: 06976202762203
Basic UDI-DI: B-06976202762203
Reference: GISPNE-502
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 07.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

BIOSYNEX S.pneumoniae

BIOSYNEX S. pneumoniae

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03700531700666
Basic UDI-DI: B-03700531700666
Reference: 1030002
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 19:26

Manufacturer products View details

BIOSYNEX S.pneumoniae BSX

BIOSYNEX S. pneumoniae BSX

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532670101567
Basic UDI-DI: B-03532670101567
Reference: 1030002_BSX
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:38

Manufacturer products View details

Mycoplasma Pneumoniae Antigen Rapid Test Device

A46710120,A46710220

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
UDI-DI: 06952804832063
Basic UDI-DI: 69528048A4671002Q
Reference: A46710
EMDN: W0105090109
EMDN description: STREP. PNEUMONIAE - RT & POC
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 28.06.2026 12:33

Manufacturer products Authorised representative products Authorised representative actors View details

S. pneumoniae Antigen Rapid Test