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Needle Holder

Needle Forceps

Class IMDR 2017/745On the marketReusable

Manufacturer: Tonglu Youshi Medical Instrument Co.,Ltd.
Manufacturer SRN: CN-MF-000030207
UDI-DI: 06949087400577
Basic UDI-DI: 69490874FQ04WE
Reference: CZQE0533
EMDN: L0499
EMDN description: ABDOMINAL SURGERY INSTRUMENTS, REUSABLE - OTHER
First on market country: Italy
Authorised representative: MedPath GmbH
Last updated: 05.08.2026 16:20

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Termometr bezdotykowy

PG-IRT1603、PG-IRT1613、PG-IRT1615

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Shenzhen Pango Medical Electronics Co., Ltd
Manufacturer SRN: CN-MF-000023018
UDI-DI: 06948423815235
Basic UDI-DI: 6948423814320B4
Reference: V0301010202
EMDN: V0301010202
EMDN description: NON-CONTACT DIGITAL THERMOMETERS
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 05.08.2026 16:20

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Infrared Forehead Thermometer

PG-IRT1602,PG-IRT1612, PG-IRT1618

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Shenzhen Pango Medical Electronics Co., Ltd
Manufacturer SRN: CN-MF-000023018
UDI-DI: 06948423815136
Basic UDI-DI: 6948423814313B7
Reference: V0301010202
EMDN: V0301010202
EMDN description: NON-CONTACT DIGITAL THERMOMETERS
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 05.08.2026 16:20

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Automatyczny cisnieniomierz stacjonarny

PG-800A series，PG-800Bseries

Class IIaMDR 2017/745On the marketActive deviceDirect markingMeasuring function

Manufacturer: Shenzhen Pango Medical Electronics Co., Ltd
Manufacturer SRN: CN-MF-000023018
UDI-DI: 06948423806820
Basic UDI-DI: 6948423813149BB
Reference: Z1203020302
EMDN: Z1203020302
EMDN description: NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS
First on market country: Poland
Authorised representative: Lotus NL B.V.
Last updated: 05.08.2026 16:20

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Rigid Endoscope

M 00430A/ M 02930A/ G 00430A/ G 02930A, G S041601H / G S291401H, G S042000H / G S291600H, G C042000H / G C291600H

Class IIaMDR 2017/745On the market

Manufacturer: Nanjing Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000019806
UDI-DI: 06948350518360
Basic UDI-DI: 69483505AB06510003CK
Reference: G C291600H
EMDN: Z12020704
EMDN description: HYSTEROSCOPES
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:20

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Cold Storage Unit (5550)

SPU-01

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145597368
Basic UDI-DI: 69471455mT89N
Reference: 010103008501
EMDN: W02060101
EMDN description: AUTOMATED SYSTEMS FOR THE MANAGEMENT OF PRE AND POST-ANALYSIS
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:20

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SteriLance

Lancing Device

Class IMDR 2017/745On the marketReusable

Manufacturer: Sterilance Medical (Suzhou) Inc.
Manufacturer SRN: CN-MF-000002860
UDI-DI: 06945630116797
Basic UDI-DI: 6945630102BB
Reference: LDE4 02-2201
EMDN: A99
EMDN description: DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 16:20

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OT8F otoscope

otoscope

Class IMDR 2017/745On the marketActive device

Manufacturer: Zumax Medical CO., LTD.
Manufacturer SRN: CN-MF-000011126
UDI-DI: 06945095507284
Basic UDI-DI: 69450955otoscopeTK
Reference: /
EMDN: Z12021007
EMDN description: MIDDLE EAR OTOSCOPES
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 05.08.2026 16:20

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5′-Nucleotidase Kit（Enzymatic Colorimetric Method）

105-003176-00、105-003119-00、105-003124-00、105-026281-00、105-026282-00、105-026283-00、105-020475-00、105-003688-00

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904035048
Basic UDI-DI: 6944904000435-NT*******ZV
Reference: 105-003119-00
EMDN: W01010101
EMDN description: 5'-NUCLEOTIDASE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:20

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Adenosine Deaminase Kit (Enzymatic Colorimetric Method)

Please see UDI-DI for details

IVD Class BIVDR 2017/746On the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904034928
Basic UDI-DI: 694490400043ADA********WS
Reference: 105-003120-00
EMDN: W01010199
EMDN description: ENZYMES - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:20

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NIBP cuff and accessories

Y000DA1

Class IMDR 2017/745On the marketActive device

Manufacturer: Shenzhen Med-link Electronics Tech Co., Ltd.
Manufacturer SRN: CN-MF-000011145
UDI-DI: 06944414082990
Basic UDI-DI: 69444140007SS
Reference: Y000T2
EMDN: Z1203020302
EMDN description: NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:20

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06944301301074

HT-1/HT-N1/HT-R1,ect

Class IIbMDR 2017/745On the marketActive deviceSingle useSterile

Manufacturer: Zhejiang Jinhua Huatong Medical Appliance Co., Ltd
Manufacturer SRN: CN-MF-000010166
UDI-DI: 06944301301074
Basic UDI-DI: 69443013010000MW
Reference: HT-N1-T
EMDN: K0201010501
EMDN description: OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:20

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FIRST AID KITS

Slo first aid kits A

Class IMDR 2017/745On the marketSingle use

Manufacturer: Xuchang Zhende Surgical Dressing Co., Ltd
Manufacturer SRN: CN-MF-000009222
UDI-DI: 06942613726592
Basic UDI-DI: 697240330FAK000001B7
Reference: 88506-4
EMDN: V0501
EMDN description: CLINICAL EMERGENCY KITS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 05.08.2026 16:20

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