EUDAMED last updated this device on May 27, 2026

Aldosterone (CLIA)

69449040AB74000085L

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
UDI-DI code: 06903053061988
Reference / catalog number: 105-029848-00

Aldosterone (CLIA) is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Placed on the EU market in Germany. 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

Aldosterone (CLIA)

69449040AB74000085L

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
UDI-DI code: 06903053061988
Reference / catalog number: 105-029848-00

View device family (Basic UDI)

Device identification

Trade name: Aldosterone (CLIA)
UDI-DI code: 06903053061988
Basic UDI-DI: 69449040AB74000085L
Reference / catalog number: 105-029848-00
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Aldosterone (CLIA)
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)06903053061988

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.

W0102060201ALDOSTERONE

Critical warnings

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

CW011
please see the IFU

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 Germany; available across 32 countries total.

Country	On market since	Until
GermanyPrimary placement	Dec 15, 2025	Dec 15, 2075
Austria	Dec 15, 2025	Dec 15, 2075
Belgium	Dec 15, 2025	Dec 15, 2075
Bulgaria	Dec 15, 2025	Dec 15, 2075
Cyprus	Dec 15, 2025	Dec 15, 2075
Czechia	Dec 15, 2025	Dec 15, 2075
Denmark	Dec 15, 2025	Dec 15, 2075
Estonia	Dec 15, 2025	Dec 15, 2075
EL	Dec 15, 2025	Dec 15, 2075
Spain	Dec 15, 2025	Dec 15, 2075
Finland	Dec 15, 2025	Dec 15, 2075
France	Dec 15, 2025	Dec 15, 2075
Croatia	Dec 15, 2025	Dec 15, 2075
Hungary	Dec 15, 2025	Dec 15, 2075
Ireland	Dec 15, 2025	Dec 15, 2075
Iceland	Dec 15, 2025	Dec 15, 2075
Italy	Dec 15, 2025	Dec 15, 2075
Liechtenstein	Dec 15, 2025	Dec 15, 2075
Lithuania	Dec 15, 2025	Dec 15, 2075
Luxembourg	Dec 15, 2025	Dec 15, 2075
Latvia	Dec 15, 2025	Dec 15, 2075
Malta	Dec 15, 2025	Dec 15, 2075
Netherlands	Dec 15, 2025	Dec 15, 2075
Norway	Dec 15, 2025	Dec 15, 2075
Poland	Dec 15, 2025	Dec 15, 2075
Portugal	Dec 15, 2025	Dec 15, 2075
Romania	Dec 15, 2025	Dec 15, 2075
Sweden	Dec 15, 2025	Dec 15, 2075
Slovenia	Dec 15, 2025	Dec 15, 2075
Slovakia	Dec 15, 2025	Dec 15, 2075
Türkiye	Dec 15, 2025	Dec 15, 2075
XI	Dec 15, 2025	Dec 15, 2075

Device identification

Trade name: Aldosterone (CLIA)
UDI-DI code: 06903053061988
Basic UDI-DI: 69449040AB74000085L
Reference / catalog number: 105-029848-00
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Aldosterone (CLIA)
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

Manufacturer information

Organization name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
SRN: CN-MF-000014156
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)06903053061988

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.

W0102060201ALDOSTERONE

Critical warnings

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

CW011
please see the IFU

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Certificates

Certificate health across this manufacturer's portfolio.

CN26/00002236Issued
Quality management systemNotified body: 1639Expiry: Apr 1, 2031
CN24/00005514Issued
Quality management systemNotified body: 1639Expiry: Aug 29, 2029
CN24/00005514Issued
Quality management systemNotified body: 1639Expiry: Aug 29, 2029
CN23/00003444Supplemented
Quality management systemNotified body: 1639Expiry: Jun 27, 2028

Certificates covering this device

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

All products by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Market distribution

Primary placement in Germany; available across 32 countries total.

Country	On market since	Until
GermanyPrimary placement	Dec 15, 2025	Dec 15, 2075
Austria	Dec 15, 2025	Dec 15, 2075
Belgium	Dec 15, 2025	Dec 15, 2075
Bulgaria	Dec 15, 2025	Dec 15, 2075
Cyprus	Dec 15, 2025	Dec 15, 2075
Czechia	Dec 15, 2025	Dec 15, 2075
Denmark	Dec 15, 2025	Dec 15, 2075
Estonia	Dec 15, 2025	Dec 15, 2075
EL	Dec 15, 2025	Dec 15, 2075
Spain	Dec 15, 2025	Dec 15, 2075
Finland	Dec 15, 2025	Dec 15, 2075
France	Dec 15, 2025	Dec 15, 2075
Croatia	Dec 15, 2025	Dec 15, 2075
Hungary	Dec 15, 2025	Dec 15, 2075
Ireland	Dec 15, 2025	Dec 15, 2075
Iceland	Dec 15, 2025	Dec 15, 2075
Italy	Dec 15, 2025	Dec 15, 2075
Liechtenstein	Dec 15, 2025	Dec 15, 2075
Lithuania	Dec 15, 2025	Dec 15, 2075
Luxembourg	Dec 15, 2025	Dec 15, 2075
Latvia	Dec 15, 2025	Dec 15, 2075
Malta	Dec 15, 2025	Dec 15, 2075
Netherlands	Dec 15, 2025	Dec 15, 2075
Norway	Dec 15, 2025	Dec 15, 2075
Poland	Dec 15, 2025	Dec 15, 2075
Portugal	Dec 15, 2025	Dec 15, 2075
Romania	Dec 15, 2025	Dec 15, 2075
Sweden	Dec 15, 2025	Dec 15, 2075
Slovenia	Dec 15, 2025	Dec 15, 2075
Slovakia	Dec 15, 2025	Dec 15, 2075
Türkiye	Dec 15, 2025	Dec 15, 2075
XI	Dec 15, 2025	Dec 15, 2075

Aldosterone (CLIA)

Aldosterone (CLIA)

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

Certificates covering this device

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

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Related devices