EUDAMED last updated this device on May 20, 2026

Tympanic Thermometer

69449040AB0100001133

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
UDI-DI code: 06903053104982
Reference / catalog number: M09G(115-090036-00)

Tympanic Thermometer is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. 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 20, 2026

Tympanic Thermometer

69449040AB0100001133

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
UDI-DI code: 06903053104982
Reference / catalog number: M09G(115-090036-00)

View device family (Basic UDI)

Device identification

Trade name: Tympanic Thermometer
UDI-DI code: 06903053104982
Basic UDI-DI: 69449040AB0100001133
Reference / catalog number: M09G(115-090036-00)
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
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)06903053104982

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.

V0301010202NON-CONTACT DIGITAL THERMOMETERS

Critical warnings

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

CW011
Follow the instructions for use and adhere to all warnings and cautions.

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

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	Feb 22, 2024	Feb 22, 2074
Austria	Feb 22, 2024	Feb 22, 2074
Belgium	Feb 22, 2024	Feb 22, 2074
Bulgaria	Feb 22, 2024	Feb 22, 2074
Cyprus	Feb 22, 2024	Feb 22, 2074
Czechia	Feb 22, 2024	Feb 22, 2074
Denmark	Feb 22, 2024	Feb 22, 2074
Estonia	Feb 22, 2024	Feb 22, 2074
EL	Feb 22, 2024	Feb 22, 2074
Spain	Feb 22, 2024	Feb 22, 2074
Finland	Feb 22, 2024	Feb 22, 2074
France	Feb 22, 2024	Feb 22, 2074
Croatia	Feb 22, 2024	Feb 22, 2074
Hungary	Feb 22, 2024	Feb 22, 2074
Ireland	Feb 22, 2024	Feb 22, 2074
Iceland	Feb 22, 2024	Feb 22, 2074
Italy	Feb 22, 2024	Feb 22, 2074
Liechtenstein	Feb 22, 2024	Feb 22, 2074
Lithuania	Feb 22, 2024	Feb 22, 2074
Luxembourg	Feb 22, 2024	Feb 22, 2074
Latvia	Feb 22, 2024	Feb 22, 2074
Malta	Feb 22, 2024	Feb 22, 2074
Netherlands	Feb 22, 2024	Feb 22, 2074
Norway	Feb 22, 2024	Feb 22, 2074
Poland	Feb 22, 2024	Feb 22, 2074
Portugal	Feb 22, 2024	Feb 22, 2074
Romania	Feb 22, 2024	Feb 22, 2074
Sweden	Feb 22, 2024	Feb 22, 2074
Slovenia	Feb 22, 2024	Feb 22, 2074
Slovakia	Feb 22, 2024	Feb 22, 2074
Türkiye	Feb 22, 2024	Feb 22, 2074
XI	Feb 22, 2024	Feb 22, 2074

Device identification

Trade name: Tympanic Thermometer
UDI-DI code: 06903053104982
Basic UDI-DI: 69449040AB0100001133
Reference / catalog number: M09G(115-090036-00)
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
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)06903053104982

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.

V0301010202NON-CONTACT DIGITAL THERMOMETERS

Critical warnings

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

CW011
Follow the instructions for use and adhere to all warnings and cautions.

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

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	Feb 22, 2024	Feb 22, 2074
Austria	Feb 22, 2024	Feb 22, 2074
Belgium	Feb 22, 2024	Feb 22, 2074
Bulgaria	Feb 22, 2024	Feb 22, 2074
Cyprus	Feb 22, 2024	Feb 22, 2074
Czechia	Feb 22, 2024	Feb 22, 2074
Denmark	Feb 22, 2024	Feb 22, 2074
Estonia	Feb 22, 2024	Feb 22, 2074
EL	Feb 22, 2024	Feb 22, 2074
Spain	Feb 22, 2024	Feb 22, 2074
Finland	Feb 22, 2024	Feb 22, 2074
France	Feb 22, 2024	Feb 22, 2074
Croatia	Feb 22, 2024	Feb 22, 2074
Hungary	Feb 22, 2024	Feb 22, 2074
Ireland	Feb 22, 2024	Feb 22, 2074
Iceland	Feb 22, 2024	Feb 22, 2074
Italy	Feb 22, 2024	Feb 22, 2074
Liechtenstein	Feb 22, 2024	Feb 22, 2074
Lithuania	Feb 22, 2024	Feb 22, 2074
Luxembourg	Feb 22, 2024	Feb 22, 2074
Latvia	Feb 22, 2024	Feb 22, 2074
Malta	Feb 22, 2024	Feb 22, 2074
Netherlands	Feb 22, 2024	Feb 22, 2074
Norway	Feb 22, 2024	Feb 22, 2074
Poland	Feb 22, 2024	Feb 22, 2074
Portugal	Feb 22, 2024	Feb 22, 2074
Romania	Feb 22, 2024	Feb 22, 2074
Sweden	Feb 22, 2024	Feb 22, 2074
Slovenia	Feb 22, 2024	Feb 22, 2074
Slovakia	Feb 22, 2024	Feb 22, 2074
Türkiye	Feb 22, 2024	Feb 22, 2074
XI	Feb 22, 2024	Feb 22, 2074

Tympanic Thermometer

Tympanic Thermometer

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

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

Substances

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Related devices