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Total Triiodothyronine Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class BIVDR 2017/746On the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230550
Basic UDI-DI: 697846523HormoneB01HP
Reference: 2×100- est
EMDN: W01020405
EMDN description: TRIIODOTHYRONINE
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 23:34

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Total Thyroxine Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230758
Basic UDI-DI: 697846523HormoneB03HT
Reference: 2×100 test
EMDN: W01020407
EMDN description: THYROXINE
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 23:34

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Thyroid Stimulating Hormone Assay kit(Chemiluminescence Immunoassay Method）

25 tests，50 tests，2×50 tests，100 tests，2×100 tests

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Dake Medical Technology Co.,Ltd
Manufacturer SRN: CN-MF-000047336
UDI-DI: 06978465230451
Basic UDI-DI: 697846523HormoneB05HX
Reference: 2×100 test
EMDN: W01020410
EMDN description: THYROID STIMULATING HORMONE
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 23:33

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06978256550102

K-Files; H-Files; Reamers; Pesso reamers; Gate drills; Barbed broaches; Paste carriers

Class IMDR 2017/745On the market

Manufacturer: Guangzhou Befull Medical Instruments Co., Ltd
Manufacturer SRN: CN-MF-000050099
UDI-DI: 06978256550102
Basic UDI-DI: 697825655EDFVE
Reference: K-Files: 6#
EMDN: L159019
EMDN description: DENTAL FINISHING RASPS AND FILES, REUSABLE
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 23:23

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06978256550010

BF-1；BF-2；BF-3；BF-4；BF-5；BF-6；BF-7；BF-8；BF-9

Class IMDR 2017/745On the marketSingle use

Manufacturer: Guangzhou Befull Medical Instruments Co., Ltd
Manufacturer SRN: CN-MF-000050099
UDI-DI: 06978256550010
Basic UDI-DI: 697825655CBBUN
Reference: BF-1
EMDN: Q010501
EMDN description: DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 23:23

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Adapter Cable

CAB7025

Class IMDR 2017/745On the market

Manufacturer: Dongguan Goochain Technology Co., Ltd
Manufacturer SRN: CN-MF-000045464
UDI-DI: 06978035540041
Basic UDI-DI: 697803554CABRP
Reference: CAB7025
EMDN: Z12062899
EMDN description: NEUROMUSCULAR STIMULATION EQUIPMENT - OTHER
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 23:13

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CAVAN Sampling Tube

CST-01/CST-02

IVD Class AIVDR 2017/746On the marketCompanion diagnosticsNear-patient testingProfessional testingSingle use

Manufacturer: Shenzhen Cavan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000052933
UDI-DI: 06977568200064
Basic UDI-DI: 697756820FIT-CST3U
Reference: CST-01
EMDN: W05019001
EMDN description: FAECES COLLECTION DEVICES
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 22:43

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Fully Automated Fecal Immunochemical Test Analyzer

FIT-1000/1200/1600/1800

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Shenzhen Cavan Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000052933
UDI-DI: 06977568200019
Basic UDI-DI: 697756820FIT-EQSV
Reference: FIT-1000
EMDN: W0201020102
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 22:43

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Rollator

3003C； 3004D

Class IMDR 2017/745On the market

Manufacturer: Yongkang Good Partner Medical Equipment Co., Ltd.
Manufacturer SRN: CN-MF-000054513
UDI-DI: 06977143380037
Basic UDI-DI: 697714338RLTVY
Reference: 3003C
EMDN: Y120609
EMDN description: WALKING FRAMES WITH CHAIR, 4 WHEELS
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 22:13

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Bath Chair

HHB-1008； HHB-1015

Class IMDR 2017/745On the market

Manufacturer: Yongkang Good Partner Medical Equipment Co., Ltd.
Manufacturer SRN: CN-MF-000054513
UDI-DI: 06977143380013
Basic UDI-DI: 697714338BTCT6
Reference: HHB-1008
EMDN: Y093303
EMDN description: FIXED AND ROTARY CHAIRS FOR BATH AND SHOWER
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 22:12

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Surface Electrode for Physical Therapy

Class IMDR 2017/745On the market

Manufacturer: Ledemei Sanhe Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000055048
UDI-DI: 06976175130078
Basic UDI-DI: 697617513SEPTS2
Reference: BW30-1
EMDN: Z12062885
EMDN description: NEUROMUSCULAR STIMULATION EQUIPMENT - CONSUMABLES
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 20:47

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Disposable ECG Electrode

LD-1/Round:∮52mm；LD-1/Round:∮40mm； LD-1/Round:∮30mm；LD-1/Round:∮30mm；Rectangular；Crescent

Class IMDR 2017/745On the marketSingle use

Manufacturer: Ledemei Sanhe Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000055048
UDI-DI: 06976175130016
Basic UDI-DI: 697617513DECGLQ
Reference: LD-1/Round:∮52mm
EMDN: C020501
EMDN description: ECG ELECTRODES
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 20:47

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SHOES COVER

17*40cm/17*38cm/15*40cm/16*40cm/15*36cm /17*42cm/18*42cm/20*45cm

Class IMDR 2017/745On the marketSingle use

Manufacturer: ANHUI MING DE MEDICAL-CARE PRODUCTS CO;LTD
Manufacturer SRN: CN-MF-000049218
UDI-DI: 06975911182777
Basic UDI-DI: 697591118SOCVTD
Reference: 17*40cm
EMDN: T020102
EMDN description: SPECIALISTIC SURGERY DRAPES
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 20:24

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FACE MASK WITH TIE

FACE MASK WITH TIE; EARLOOP FACE MASK; CHILD FACE MASK;

Class IMDR 2017/745On the marketSingle use

Manufacturer: ANHUI MING DE MEDICAL-CARE PRODUCTS CO;LTD
Manufacturer SRN: CN-MF-000049218
UDI-DI: 06975911182746
Basic UDI-DI: 697591118FCMKNW
Reference: FACE MASK WITH TIE
EMDN: T020604
EMDN description: MEDICAL USE FACE MASKS, TYPE II AND IIR
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

MOB CAP

MOB CAP/BOUFFANT CAP/NURSE CAP /NONWOVEN CAP/SURGICAL CAP/DOCTOR CAP

Class IMDR 2017/745On the marketSingle use

Manufacturer: ANHUI MING DE MEDICAL-CARE PRODUCTS CO;LTD
Manufacturer SRN: CN-MF-000049218
UDI-DI: 06975911182685
Basic UDI-DI: 697591118CLPCPF
Reference: MOB CAP
EMDN: T0207
EMDN description: CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 20:24

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ISOLATION GOWN

S/ M /L /XL /XXL/XXL/XXXL

Class IMDR 2017/745On the marketSingle use

Manufacturer: ANHUI MING DE MEDICAL-CARE PRODUCTS CO;LTD
Manufacturer SRN: CN-MF-000049218
UDI-DI: 06975911182623
Basic UDI-DI: 697591118ISGNRP
Reference: S
EMDN: T0205
EMDN description: NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 20:24

Manufacturer products Authorised representative products Authorised representative actors View details

DISPOSABLE MEDICAL FACE MASK

YF1001, YF1002, YF1003, YF1004, YF1005, YF1006, YF1007

Class IMDR 2017/745On the marketSingle use

Manufacturer: Wuhan Youfu International Trade Co., Ltd
Manufacturer SRN: CN-MF-000013519
UDI-DI: 06975908950044
Basic UDI-DI: 697590895DMFMUU
Reference: YF1001
EMDN: T020604
EMDN description: MEDICAL USE FACE MASKS, TYPE II AND IIR
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 20:23

Manufacturer products Authorised representative products Authorised representative actors View details

DISPOSABLE GOWN

YF4004, YF4001, YF4006

Class IMDR 2017/745On the marketSingle use

Manufacturer: Wuhan Youfu International Trade Co., Ltd
Manufacturer SRN: CN-MF-000013519
UDI-DI: 06975908950037
Basic UDI-DI: 697590895CPEGUM
Reference: YF4004
EMDN: T0205
EMDN description: NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 20:23

Manufacturer products Authorised representative products Authorised representative actors View details

LAB COAT

YF6001，YF6002

Class IMDR 2017/745On the marketSingle use

Manufacturer: Wuhan Youfu International Trade Co., Ltd
Manufacturer SRN: CN-MF-000013519
UDI-DI: 06975908950013
Basic UDI-DI: 697590895LABCTQ
Reference: YF6001
EMDN: T0299
EMDN description: PROTECTION DRAPES AND GARMENTS - OTHER
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 20:23

Manufacturer products Authorised representative products Authorised representative actors View details

DISPOSABLE VINYL EXAMINATION GLOVES

S，M，L，XL，XXL

Class IMDR 2017/745On the marketSingle use

Manufacturer: ANHUI ANCHO RUBBER&PLASTIC TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000054855
UDI-DI: 06974517220012
Basic UDI-DI: 697451722DVEGN7
Reference: 201
EMDN: T01020201
EMDN description: VINYL EXAMINATION / TREATMENT GLOVES
First on market country: Austria
Authorised representative: HyperCert Limited B.V.
Last updated: 02.07.2026 16:25

Manufacturer products Authorised representative products Authorised representative actors View details