BEUDAMED

EU Manufacturer 🇨🇳 China Active

Shanghai United Imaging Healthcare Co.,Ltd.

SRN: CN-MF-000008501 · Chengbei Road, Jiading District 2258, 201807 Shanghai, China

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Basic UDI-DIs

Total Devices

On Market

Off Market

Certificates

Valid

Expiring < 6mo

Countries

Basic Information

Address: Chengbei Road, Jiading District 2258, 201807 Shanghai, China
Email: [email protected]

Regulatory Overview

Regulation

Eu Mdr 33

Eu Mdd 22

Classification

Eu Md Class 2b 36

Eu Md Class 2a 19

Device Types

Certificate Health

Total

Valid

Expiring < 6mo

Expired / Withdrawn

Certificates by Expiry Year

Type	Number	Notified Body	Legislation	Issue Date	Expiry Date	Status
MDD Annex II (excluding section 4)	HD 601461080001	TÜV Rheinland LGA Products GmbH			May 26, 2024
MDD Annex II (excluding section 4)	No.G1 087510 0034 Rev.02	TÜV SÜD Product Service GmbH			May 26, 2024
MDD Annex II (excluding section 4)	G1 087510 0034 Rev.02	TÜV SÜD Product Service GmbH			May 26, 2024
MDR QMS	HZ 2057357-1	TÜV Rheinland LGA Products GmbH	MDR	Jul 2023	Jul 30, 2028	Issued
MDD Annex II (excluding section 4)	HD 60146108 0001	TÜV Rheinland LGA Products GmbH			Dec 31, 2028

Market Presence

Devices from this manufacturer are available in 24 countries across Europe.

🇦🇹 Austria 🇧🇪 Belgium 🇨🇾 Cyprus 🇩🇪 Germany 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇷 Greece 🇪🇸 Spain 🇫🇷 France 🇭🇷 Croatia 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇸 Iceland 🇮🇹 Italy 🇱🇮 Liechtenstein 🇱🇹 Lithuania 🇱🇺 Luxembourg 🇱🇻 Latvia 🇲🇹 Malta 🇳🇱 Netherlands 🇵🇱 Poland 🇷🇴 Romania 🇸🇮 Slovenia 🇹🇷 Türkiye

Device Portfolio

Name	Regulation	Classification	Market Status	Certificates
CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T	EU MDR	Eu Md Class 2a	On Market	0
CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T	EU MDD	Eu Md Class 2a	On Market	1
CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 2T AND LESS THAN OR EQUAL TO 4T	EU MDR	Eu Md Class 2a	On Market	0
CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD GREATER THAN 4T	EU MDR	Eu Md Class 2a	On Market	0
CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T	EU MDR	Eu Md Class 2a	On Market	0
CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T	EU MDR	Eu Md Class 2a	On Market	0
CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T	EU MDR	Eu Md Class 2a	On Market	0
CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T	EU MDR	Eu Md Class 2a	On Market	0
COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE	EU MDR	Eu Md Class 2a	On Market	0
COMPUTED TOMOGRAPHS (CT) - MEDICAL DEVICE SOFTWARE	EU MDR	Eu Md Class 2a	On Market	0
COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS	EU MDR	Eu Md Class 2b	On Market	0
COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS	EU MDD	Eu Md Class 2b	On Market	1
COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS	EU MDD	Eu Md Class 2b	On Market	1
COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS	EU MDR	Eu Md Class 2b	On Market	0
COMPUTED TOMOGRAPHS - 128 LAYERS OR MORE BUT LESS THAN 256 LAYERS	EU MDR	Eu Md Class 2b	On Market	0
COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS	EU MDD	Eu Md Class 2b	On Market	1
COMPUTED TOMOGRAPHS - 16 LAYERS OR MORE BUT LESS THAN 64 LAYERS	EU MDD	Eu Md Class 2b	On Market	1
COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE	EU MDD	Eu Md Class 2b	On Market	1
COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE	EU MDR	Eu Md Class 2b	On Market	0
COMPUTED TOMOGRAPHS - 256 LAYERS OR MORE	EU MDR	Eu Md Class 2b	On Market	0
COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS	EU MDD	Eu Md Class 2b	On Market	1
COMPUTED TOMOGRAPHS - 64 LAYERS OR MORE BUT LESS THAN 128 LAYERS	EU MDR	Eu Md Class 2b	On Market	0
CT/PET SYSTEMS	EU MDR	Eu Md Class 2b	On Market	0
CT/PET SYSTEMS	EU MDR	Eu Md Class 2b	On Market	0
CT/PET SYSTEMS	EU MDR	Eu Md Class 2b	On Market	0
CT/PET SYSTEMS	EU MDR	Eu Md Class 2b	On Market	0
CT/PET SYSTEMS	EU MDR	Eu Md Class 2b	On Market	0
CT/PET SYSTEMS	EU MDD	Eu Md Class 2b	On Market	1
CT/PET SYSTEMS	EU MDD	Eu Md Class 2b	On Market	1
CT/PET SYSTEMS	EU MDD	Eu Md Class 2b	On Market	1
CT/PET SYSTEMS	EU MDD	Eu Md Class 2b	On Market	1
DIGITAL MAMMOGRAPHY SYSTEMS	EU MDR	Eu Md Class 2b	On Market	0
DIGITAL MAMMOGRAPHY SYSTEMS	EU MDD	Eu Md Class 2b	On Market	1
DIGITAL MAMMOGRAPHY SYSTEMS	EU MDD	Eu Md Class 2b	On Market	1
DIRECT DIGITAL TELERADIOGRAPHS	EU MDR	Eu Md Class 2b	On Market	0
DIRECT DIGITAL TELERADIOGRAPHS	EU MDR	Eu Md Class 2b	On Market	0
DIRECT DIGITAL TELERADIOGRAPHS	EU MDD	Eu Md Class 2b	On Market	1
DIRECT DIGITAL TELERADIOGRAPHS	EU MDD	Eu Md Class 2b	On Market	1
DIRECT DIGITAL TELERADIOGRAPHS	EU MDD	Eu Md Class 2b	On Market	1
DIRECT DIGITAL TELERADIOGRAPHS	EU MDD	Eu Md Class 2b	On Market	1
DIRECT DIGITAL TELERADIOGRAPHS	EU MDD	Eu Md Class 2b	On Market	1
DIRECT DIGITAL TELERADIOGRAPHS	EU MDD	Eu Md Class 2b	On Market	1
INTEGRATED CT/PET SYSTEMS - MEDICAL DEVICE SOFTWARE	EU MDD	Eu Md Class 2a	On Market	1
INTEGRATED CT/PET SYSTEMS - MEDICAL DEVICE SOFTWARE	EU MDR	Eu Md Class 2a	On Market	0
INTEGRATED CT/PET SYSTEMS - MEDICAL DEVICE SOFTWARE	EU MDR	Eu Md Class 2a	On Market	0
LINEAR ACCELERATORS - MEDICAL DEVICE SOFTWARE	EU MDR	Eu Md Class 2b	On Market	0
LINEAR ACCELERATORS - MEDICAL DEVICE SOFTWARE	EU MDR	Eu Md Class 2b	On Market	0
MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE	EU MDR	Eu Md Class 2a	On Market	0
MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE	EU MDR	Eu Md Class 2a	On Market	0
MAMMOGRAPHY SYSTEMS - MEDICAL DEVICE SOFTWARE	EU MDD	Eu Md Class 2a	On Market	1

View all 55 devices →

PRRC

Name

Shumei Wang

Country

🇨🇳 China

Authorized Representative

Name

Shanghai International Holding Corp. GmbH(Europe)

Country

🇩🇪 Germany

Importer

Name

United Imaging Healthcare Poland Sp. z o.o.

Country

🇵🇱 Poland

Notified Bodies

TÜV Rheinland LGA Products GmbH

3 certs

TÜV SÜD Product Service GmbH

2 certs

Competent Authority

Name

DE/CA05 - Behorde fur Justiz und Verbraucherschutz

Country

🇩🇪 Germany

More about this competent authority →

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