EUDAMED last updated this device on May 26, 2026

ICA2229

B-06974541565431

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: 06974541565431
Reference / catalog number: ICA2229

ICA2229 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 Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

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Country
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EUDAMED last updated this device on May 26, 2026

ICA2229

B-06974541565431

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: 06974541565431
Reference / catalog number: ICA2229

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 06974541565431
Basic UDI-DI: B-06974541565431
Reference / catalog number: ICA2229
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: Used for in vitro qualitative detection of follicle stimulating hormone (FSH) in women's urine, clinically used as an aid in the diagnosis of ovarian diseases.
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)06974541565431

EMDN nomenclature code(s)

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

W0102160301FSH - RT & POC

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 Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 06974541565431
Basic UDI-DI: B-06974541565431
Reference / catalog number: ICA2229
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: Used for in vitro qualitative detection of follicle stimulating hormone (FSH) in women's urine, clinically used as an aid in the diagnosis of ovarian diseases.
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)06974541565431

EMDN nomenclature code(s)

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

W0102160301FSH - RT & POC

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 Ireland; available across 1 country total.

Country	On market since	Until
IrelandPrimary placement		Still on market

ICA2229

ICA2229

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

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