EUDAMED last updated this device on May 27, 2026

Chlamydia Rapid Test

6970277510015CY3

On the marketIVDR Class C

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Hangzhou Alltest Biotech.Co.,Ltd.
UDI-DI code: 06936983185820
Reference / catalog number: ICH-N502HB-02

Chlamydia Rapid Test is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. Manufactured by Hangzhou Alltest Biotech.Co.,Ltd.. Placed on the EU market in Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Role
Country
Date of registration
Address

EUDAMED last updated this device on May 27, 2026

Chlamydia Rapid Test

6970277510015CY3

On the marketIVDR Class C

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Hangzhou Alltest Biotech.Co.,Ltd.
UDI-DI code: 06936983185820
Reference / catalog number: ICH-N502HB-02

View device family (Basic UDI)

Device identification

Trade name: Chlamydia Rapid Test
UDI-DI code: 06936983185820
Basic UDI-DI: 6970277510015CY3
Reference / catalog number: ICH-N502HB-02
Issuing entity: GS1

Classification

Risk category: IVDR Class C
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 2
Additional product description: The test is a rapid chromatographic immunoassay for the qualitative detection of Chlamydia trachomatis antigens in female cervical swab or male urethral swab specimens to aid in the diagnosis of Chlamydia infection. The test is for self-testing use. The test is not automated. For in vitro diagnostic use only.
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)06936983185820

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

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

W0105090101CHLAMYDIA AG - RT & POC

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Market distribution

Primary placement in Ireland; available across 2 countries total.

Country	On market since	Until
IrelandPrimary placement		Still on market
Croatia		Still on market

Device identification

Trade name: Chlamydia Rapid Test
UDI-DI code: 06936983185820
Basic UDI-DI: 6970277510015CY3
Reference / catalog number: ICH-N502HB-02
Issuing entity: GS1

Classification

Risk category: IVDR Class C
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 2
Additional product description: The test is a rapid chromatographic immunoassay for the qualitative detection of Chlamydia trachomatis antigens in female cervical swab or male urethral swab specimens to aid in the diagnosis of Chlamydia infection. The test is for self-testing use. The test is not automated. For in vitro diagnostic use only.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: Hangzhou Alltest Biotech.Co.,Ltd.
SRN: CN-MF-000010710
Manufacturer status: —

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06936983185820

UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

EMDN nomenclature code(s)

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

W0105090101CHLAMYDIA AG - RT & POC

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

Certificate health across this manufacturer's portfolio.

EU-QMS-FI-08820-800081-2026Issued
Quality management systemNotified body: 3018Expiry: Apr 16, 2031
EU-TDA-FI-51326-800081-2026Issued
Technical documentationNotified body: 3018Expiry: Apr 16, 2031
EU-QMS-FI-08820-800081-2026Issued
Quality management systemNotified body: 3018Expiry: Apr 16, 2031
CN26/00001622Issued
Quality management systemNotified body: 1639Expiry: Mar 10, 2031

Legacy certificates

Certificate number: EU-TDA-FI-51326-800081-2026
Type: Technical documentation
Notified body: Sertio Oy (3018)
Validity: Apr 23, 2026 → Apr 16, 2031

Certificates covering this device

EU-TDA-FI-51326-800081-2026Issued
Technical documentationNotified body: 3018Expiry: Apr 16, 2031

All products by Hangzhou Alltest Biotech.Co.,Ltd.

Market distribution

Primary placement in Ireland; available across 2 countries total.

Country	On market since	Until
IrelandPrimary placement		Still on market
Croatia		Still on market

Chlamydia Rapid Test

Chlamydia Rapid Test

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Regulatory

Lifecycle

Certificates

Legacy certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Legacy certificates

Certificates covering this device

Related devices