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Low Speed Refrigerated Centrifuge

TDL-5M, TDL-6, TDL-6M

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Sichuan Shuke Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000049519
UDI-DI: 06979069720126
Basic UDI-DI: 697906972TDLZF
Reference: TDL-5M
EMDN: W02069005
EMDN description: REFRIGERATED CENTRIFUGES
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.07.2026 00:23

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Low Speed Centrifuge

TD-4,TD-4Z,TD-5,TD-5Z,TD-400,TD-500,TD-600,TD-5M,TD-6M,TD-450,TD-4B

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Sichuan Shuke Instrument Co., Ltd.
Manufacturer SRN: CN-MF-000049519
UDI-DI: 06979069720010
Basic UDI-DI: 697906972TD7H
Reference: TD-4
EMDN: W02069003
EMDN description: CENTRIFUGES
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.07.2026 00:23

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Intelligent Fully Automatic Endotoxin Detection Robot System (Qilin Endomaster Series)

Qilin Endomaster

IVD Class AIVDR 2017/746On the marketInstrumentKitProfessional testingSingle use

Manufacturer: Xiamen Bioendo Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027676
UDI-DI: 6978918720164
Basic UDI-DI: 697891872QES001WX
Reference: Qilin Endomaster Series
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.07.2026 00:20

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Limulus Amebocyte Lysate (Gel Method)

IVD Class AIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Xiamen Bioendo Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027676
UDI-DI: 6978918720089
Basic UDI-DI: 697891872LAL001RZ
Reference: T0850108
EMDN: W0503900101
EMDN description: AGITATION RODS
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.07.2026 00:20

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Pyrogen Test Kit (Monocyte Activation Test, MAT)

IVD Class AIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Xiamen Bioendo Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027676
UDI-DI: 6978918720072
Basic UDI-DI: 697891872MAT001U6
Reference: W050390
EMDN: W0503900101
EMDN description: AGITATION RODS
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.07.2026 00:20

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rFC Endotoxin Test Kit (Recombinant Factor C Fluorometric Assay)

This device is not currently linked with any other devices.

IVD Class AIVDR 2017/746On the marketDirect markingKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Xiamen Bioendo Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027676
UDI-DI: 6978918720065
Basic UDI-DI: 697891872RFC001U7
Reference: RFC001
EMDN: W0503900101
EMDN description: AGITATION RODS
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.07.2026 00:20

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Intelligent Fully Automatic Endotoxin And MAT Detection Robot System (Phoenix Q Series)

Phoenix Q5

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: Xiamen Bioendo Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027676
UDI-DI: 06978918720157
Basic UDI-DI: 697891872PQS0012R
Reference: Phoenix Q5
EMDN: W0201030101
EMDN description: MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput <= 800 test/h)
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.07.2026 00:15

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rCR Endotoxin Test Kit (Recombinant Cascade Reagents Chromogenic Assay)

IVD Class AIVDR 2017/746On the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Xiamen Bioendo Technology Co., Ltd.
Manufacturer SRN: CN-MF-000027676
UDI-DI: 06978918720058
Basic UDI-DI: 697891872RCR001WF
Reference: W050390
EMDN: W0503900101
EMDN description: AGITATION RODS
First on market country: Austria
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 03.07.2026 00:15

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06978729410117

Single-use face mask (Non-sterile)

Class IMDR 2017/745On the marketSingle use

Manufacturer: Zhejiang The Purples Protective Products Co.,Ltd
Manufacturer SRN: CN-MF-000055134
UDI-DI: 06978729410117
Basic UDI-DI: 697872941SUFMYY
Reference: Model:TP-001 Spec:175*95mm
EMDN: T020604
EMDN description: MEDICAL USE FACE MASKS, TYPE II AND IIR
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 02.07.2026 23:59

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06978729410018

Protective Butterfly Mask

Class IMDR 2017/745On the marketSingle use

Manufacturer: Zhejiang The Purples Protective Products Co.,Ltd
Manufacturer SRN: CN-MF-000055134
UDI-DI: 06978729410018
Basic UDI-DI: 697872941PBMYR
Reference: Model: Q3 Spec:125*155cm
EMDN: T020699
EMDN description: MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 02.07.2026 23:59

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AllDx

M-HA

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentNear-patient testingProfessional testing

Manufacturer: Hangzhou Aokai Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000048311
UDI-DI: 06978467910054
Basic UDI-DI: 697846791MHA000013R
Reference: M-HA-0014
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 02.07.2026 23:35

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AllDx

M-UA

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Hangzhou Aokai Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000048311
UDI-DI: 06978467910009
Basic UDI-DI: 697846791MUA00001AN
Reference: M-UA-0014
EMDN: W0201069099
EMDN description: VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 02.07.2026 23:35

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06978386220012

Dental Film

Class IMDR 2017/745On the marketSingle use

Manufacturer: Shanghai Uretech Film Materials Co., Ltd.
Manufacturer SRN: CN-MF-000046804
UDI-DI: 06978386220012
Basic UDI-DI: 697838622DF5T
Reference: UreMega011 076125
EMDN: Q010599
EMDN description: DENTAL INSTRUMENTS, SINGLE-USE - OTHER
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 02.07.2026 23:30

Manufacturer products Authorised representative products Authorised representative actors View details

HISPA

L-21, L-45, L-150, L-180, L-230, L-360

Class IMDR 2017/745On the marketSingle use

Manufacturer: Guangdong Hispa Med Co., Ltd.
Manufacturer SRN: CN-MF-000045399
UDI-DI: 06977849480185
Basic UDI-DI: 697784948018TM
Reference: L-21
EMDN: A060102
EMDN description: SURGICAL DRAINAGE CONNECTION MEDICAL TUBES
First on market country: Germany
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 02.07.2026 23:04

Manufacturer products Authorised representative products Authorised representative actors View details

HISPA

see Appendix I Model

Class IMDR 2017/745On the marketSingle use

Manufacturer: Guangdong Hispa Med Co., Ltd.
Manufacturer SRN: CN-MF-000045399
UDI-DI: 06977849480000
Basic UDI-DI: 697784948008TJ
Reference: G100933
EMDN: A060199
EMDN description: SURGICAL DRAINAGE SYSTEMS - OTHER
First on market country: Germany
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 02.07.2026 23:04

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Ultrasound Therapy Workstation

XMS-UET2

Class IIaMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Xemis Medical Technology (Shenzhen) Co., Ltd.
Manufacturer SRN: CN-MF-000045397
UDI-DI: 06977593370015
Basic UDI-DI: 6977593372A001CL
Reference: XMS-UET2
EMDN: Z120610
EMDN description: ULTRASOUND THERAPY EQUIPMENT
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 02.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

06975783736610

Powder jet handpiece

Class IMDR 2017/745On the marketDirect marking

Manufacturer: Baru Foshan Medical Technology Co.,Limited
Manufacturer SRN: CN-MF-000045880
UDI-DI: 06975783736610
Basic UDI-DI: 697578373PJH001TQ
Reference: BR-806
EMDN: Q0199
EMDN description: ODONTOLOGY DEVICES - OTHER
First on market country: Austria
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 02.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

06975783736313

Intra Oral Camera

Class IMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: Baru Foshan Medical Technology Co.,Limited
Manufacturer SRN: CN-MF-000045880
UDI-DI: 06975783736313
Basic UDI-DI: 697578373IOC001RH
Reference: BR-503
EMDN: Q0199
EMDN description: ODONTOLOGY DEVICES - OTHER
First on market country: Austria
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 02.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

06975783736009

Dental loupes

Class IMDR 2017/745On the marketActive device

Manufacturer: Baru Foshan Medical Technology Co.,Limited
Manufacturer SRN: CN-MF-000045880
UDI-DI: 06975783736009
Basic UDI-DI: 697578373DL001LH
Reference: BR-804
EMDN: Q0199
EMDN description: ODONTOLOGY DEVICES - OTHER
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 02.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details

06975783734500

Electric lab motor

Class IMDR 2017/745On the marketActive device

Manufacturer: Baru Foshan Medical Technology Co.,Limited
Manufacturer SRN: CN-MF-000045880
UDI-DI: 06975783734500
Basic UDI-DI: 697578373ELM001R2
Reference: BR-204
EMDN: Q0199
EMDN description: ODONTOLOGY DEVICES - OTHER
First on market country: Spain
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 02.07.2026 19:46

Manufacturer products Authorised representative products Authorised representative actors View details