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

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Silicone 2-way Foley Balloon Catheter

Class IIbNot specifiedOn the marketSingle useSterile

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04711182628567
Basic UDI-DI: B-04711182628567
Reference: 1827-0018
EMDN: U020299
EMDN description: URETERAL CATHETERS WITH BALLOON - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 25.09.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

Silicone 2-way Foley Balloon Catheter

Class IIbNot specifiedOn the marketSingle useSterile

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04711182628550
Basic UDI-DI: B-04711182628550
Reference: 1827-0020
EMDN: U020299
EMDN description: URETERAL CATHETERS WITH BALLOON - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 25.09.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

Silicone 2-way Foley Balloon Catheter

Class IIbNot specifiedOn the marketSingle useSterile

Manufacturer: FORTUNE MEDICAL INSTRUMENT CORP.
Manufacturer SRN: TW-MF-000009221
UDI-DI: 04711182628543
Basic UDI-DI: B-04711182628543
Reference: 1827-0022
EMDN: U020299
EMDN description: URETERAL CATHETERS WITH BALLOON - OTHER
First on market country: Italy
Authorised representative: Emergo Europe B.V.
Last updated: 25.09.2026 09:26

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Multi-Control

Control Level 1: 1×15mL/bottle Control Level 2: 1×15mL/bottle Control Level 3: 1×15mL/bottle

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202208942
Basic UDI-DI: B-06942202208942
Reference: 3010242
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 25.09.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Multi-Control

Control Level 1: 1×40mL/bottle Control Level 2: 1×40mL/bottle Control Level 3: 1×40mL/bottle

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202208959
Basic UDI-DI: B-06942202208959
Reference: 3010243
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 25.09.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Conductivity Analysis Calibrator

Level 1：1×7mL/bottle; Level 2：1×7mL/bottle; Level 3：1×7mL/bottle.

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202204050
Basic UDI-DI: B-06942202204050
Reference: 3022362
EMDN: W010106020602
EMDN description: URINE TESTING CALIBRATORS AND STANDARDS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 25.09.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

Urine Conductivity Analysis Control

Level 1：1×7mL/bottle; Level 2：1×7mL/bottle.

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202204067
Basic UDI-DI: B-06942202204067
Reference: 3022346
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 25.09.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Control for Urine Physical and Chemical Analysis

Control level 1: 4×10mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202204159
Basic UDI-DI: B-06942202204159
Reference: 3022336
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 25.09.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

Multi-Control for Urine Physical and Chemical Analysis

Control level 2: 4×10mL

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202204166
Basic UDI-DI: B-06942202204166
Reference: 3022329
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 25.09.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

H series urine analyzer Control liquid for Turbidity

8ml/vial（200NTU）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202204180
Basic UDI-DI: B-06942202204180
Reference: 3022337
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 25.09.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

H series urine analyzer Control liquid for Turbidity

8ml/vial（700NTU）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202204197
Basic UDI-DI: B-06942202204197
Reference: 3022364
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 25.09.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

H series urine analyzer Color Control

8ml/vial （Red）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202204227
Basic UDI-DI: B-06942202204227
Reference: 3022347
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 25.09.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

H series urine analyzer Color Control

8ml/vial （Green）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202204234
Basic UDI-DI: B-06942202204234
Reference: 3022313
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 25.09.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

H series urine analyzer Color Control

8ml/vial （Blue）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202204241
Basic UDI-DI: B-06942202204241
Reference: 3022356
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 25.09.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

H series urine analyzer Control liquid for Specific gravity

8ml/vial （1.005）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202204289
Basic UDI-DI: B-06942202204289
Reference: 3022314
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 25.09.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

H series urine analyzer Control liquid for Specific gravity

8ml/vial （1.030）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202204296
Basic UDI-DI: B-06942202204296
Reference: 3022339
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 25.09.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

H series urine analyzer Control liquid for Specific gravity

8ml/vial （1.050）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202204302
Basic UDI-DI: B-06942202204302
Reference: 3022331
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 25.09.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

H series urine analyzer Calibration liquid for Specific gravity

8ml/vial （1.040）

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202204340
Basic UDI-DI: B-06942202204340
Reference: 3022357
EMDN: W010106020602
EMDN description: URINE TESTING CALIBRATORS AND STANDARDS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 25.09.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Control

8ml/bottle (Positive)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202204081
Basic UDI-DI: B-06942202204081
Reference: 3022363
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 25.09.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details

Urinalysis Control

8ml/bottle (Negative)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202204098
Basic UDI-DI: B-06942202204098
Reference: 3022328
EMDN: W010106020601
EMDN description: URINE TESTING CONTROLS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 25.09.2026 08:20

Manufacturer products Authorised representative products Authorised representative actors View details