EUDAMED last updated this device on May 12, 2026

Hemoglobin A1c Eluent A

69449040AB700001945

On the marketIVDR Class A

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: 06903053088947
Reference / catalog number: 105-048453-00

Hemoglobin A1c Eluent A is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. 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 12, 2026

Hemoglobin A1c Eluent A

69449040AB700001945

On the marketIVDR Class A

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: 06903053088947
Reference / catalog number: 105-048453-00

View device family (Basic UDI)

Device identification

Trade name: Hemoglobin A1c Eluent A
UDI-DI code: 06903053088947
Basic UDI-DI: 69449040AB700001945
Reference / catalog number: 105-048453-00
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Hemoglobin A1c Eluent A
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)06903053088947

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.

W0103010299OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER

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 20, 2024	Dec 20, 2074
Austria	Dec 20, 2024	Dec 20, 2074
Belgium	Dec 20, 2024	Dec 20, 2074
Bulgaria	Dec 20, 2024	Dec 20, 2074
Cyprus	Dec 20, 2024	Dec 20, 2074
Czechia	Dec 20, 2024	Dec 20, 2074
Denmark	Dec 20, 2024	Dec 20, 2074
Estonia	Dec 20, 2024	Dec 20, 2074
EL	Dec 20, 2024	Dec 20, 2074
Spain	Dec 20, 2024	Dec 20, 2074
Finland	Dec 20, 2024	Dec 20, 2074
France	Dec 20, 2024	Dec 20, 2074
Croatia	Dec 20, 2024	Dec 20, 2074
Hungary	Dec 20, 2024	Dec 20, 2074
Ireland	Dec 20, 2024	Dec 20, 2074
Iceland	Dec 20, 2024	Dec 20, 2074
Italy	Dec 20, 2024	Dec 20, 2074
Liechtenstein	Dec 20, 2024	Dec 20, 2074
Lithuania	Dec 20, 2024	Dec 20, 2074
Luxembourg	Dec 20, 2024	Dec 20, 2074
Latvia	Dec 20, 2024	Dec 20, 2074
Malta	Dec 20, 2024	Dec 20, 2074
Netherlands	Dec 20, 2024	Dec 20, 2074
Norway	Dec 20, 2024	Dec 20, 2074
Poland	Dec 20, 2024	Dec 20, 2074
Portugal	Dec 20, 2024	Dec 20, 2074
Romania	Dec 20, 2024	Dec 20, 2074
Sweden	Dec 20, 2024	Dec 20, 2074
Slovenia	Dec 20, 2024	Dec 20, 2074
Slovakia	Dec 20, 2024	Dec 20, 2074
Türkiye	Dec 20, 2024	Dec 20, 2074
XI	Dec 20, 2024	Dec 20, 2074

Device identification

Trade name: Hemoglobin A1c Eluent A
UDI-DI code: 06903053088947
Basic UDI-DI: 69449040AB700001945
Reference / catalog number: 105-048453-00
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Hemoglobin A1c Eluent A
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)06903053088947

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.

W0103010299OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER

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 20, 2024	Dec 20, 2074
Austria	Dec 20, 2024	Dec 20, 2074
Belgium	Dec 20, 2024	Dec 20, 2074
Bulgaria	Dec 20, 2024	Dec 20, 2074
Cyprus	Dec 20, 2024	Dec 20, 2074
Czechia	Dec 20, 2024	Dec 20, 2074
Denmark	Dec 20, 2024	Dec 20, 2074
Estonia	Dec 20, 2024	Dec 20, 2074
EL	Dec 20, 2024	Dec 20, 2074
Spain	Dec 20, 2024	Dec 20, 2074
Finland	Dec 20, 2024	Dec 20, 2074
France	Dec 20, 2024	Dec 20, 2074
Croatia	Dec 20, 2024	Dec 20, 2074
Hungary	Dec 20, 2024	Dec 20, 2074
Ireland	Dec 20, 2024	Dec 20, 2074
Iceland	Dec 20, 2024	Dec 20, 2074
Italy	Dec 20, 2024	Dec 20, 2074
Liechtenstein	Dec 20, 2024	Dec 20, 2074
Lithuania	Dec 20, 2024	Dec 20, 2074
Luxembourg	Dec 20, 2024	Dec 20, 2074
Latvia	Dec 20, 2024	Dec 20, 2074
Malta	Dec 20, 2024	Dec 20, 2074
Netherlands	Dec 20, 2024	Dec 20, 2074
Norway	Dec 20, 2024	Dec 20, 2074
Poland	Dec 20, 2024	Dec 20, 2074
Portugal	Dec 20, 2024	Dec 20, 2074
Romania	Dec 20, 2024	Dec 20, 2074
Sweden	Dec 20, 2024	Dec 20, 2074
Slovenia	Dec 20, 2024	Dec 20, 2074
Slovakia	Dec 20, 2024	Dec 20, 2074
Türkiye	Dec 20, 2024	Dec 20, 2074
XI	Dec 20, 2024	Dec 20, 2074

Hemoglobin A1c Eluent A

Hemoglobin A1c Eluent A

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