EUDAMED last updated this device on May 26, 2026

PR2024-UT01

B-06974541565509

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: BioTeke Corporation（Wuxi）Co., Ltd
UDI-DI code: 06974541565509
Reference / catalog number: PR2024-UT01

PR2024-UT01 is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by BioTeke Corporation（Wuxi）Co., Ltd. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Role
Country
Date of registration
Address

EUDAMED last updated this device on May 26, 2026

PR2024-UT01

B-06974541565509

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: BioTeke Corporation（Wuxi）Co., Ltd
UDI-DI code: 06974541565509
Reference / catalog number: PR2024-UT01

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 06974541565509
Basic UDI-DI: B-06974541565509
Reference / catalog number: PR2024-UT01
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: This kit is qualitative in vitro test of 19 common pathogens DNA and 12 common drug resistance(DR) genes in urine specimens obtained from individuals with urinary tract infections (UTI).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06974541565509

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W01010999MULTIPLE PARAMETERS URINE TESTING - OTHER

Critical warnings

No critical warnings reported for this device.

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 06974541565509
Basic UDI-DI: B-06974541565509
Reference / catalog number: PR2024-UT01
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: This kit is qualitative in vitro test of 19 common pathogens DNA and 12 common drug resistance(DR) genes in urine specimens obtained from individuals with urinary tract infections (UTI).
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: BioTeke Corporation（Wuxi）Co., Ltd
SRN: CN-MF-000007517
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06974541565509

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W01010999MULTIPLE PARAMETERS URINE TESTING - OTHER

Critical warnings

No critical warnings reported for this device.

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

Certificate health across this manufacturer's portfolio.

EU-TDA-FI-43117-800031-2025Issued
Technical documentationNotified body: 3018Expiry: May 30, 2030
EU-QMS-FI-40845-800031-2025Issued
Quality management systemNotified body: 3018Expiry: May 30, 2030

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

All products by BioTeke Corporation（Wuxi）Co., Ltd

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

PR2024-UT01

PR2024-UT01

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates covering this device

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Related devices