200 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Country: China
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Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG;UI20 BK, UI20 BL, UI20 BR, UI20 BS, UI20 DB, UI20 GP, UI20 GR, UI20 MP, UI20 PN, UI20 PW, UI20 RE, UI20 WH; UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB,UI06 PR, UI06 OG,UI06RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG; UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU; UI04 MK, UI04 BN, UI04 BU, UI04 CB, UI04 GY, UI04 LG, UI04 DG, UI04 PL,
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Shandong Lovego Industrial Co., Ltd
Manufacturer
🇨🇳 China·1 Basic UDI-DI·1 Device
DLAB Scientific Co., Ltd.
Manufacturer
🇨🇳 China·3 Importers
LOVEGO
Device
EU MDR
·
Eu Md Class 2b
·Shandong Lovego Industrial Co., Ltd·On the market·1 country
Abon Biopharm(Hangzhou) Co., Ltd
Manufacturer
🇨🇳 China·123 Basic UDI-DIs·123 Devices·1 Importer·TÜV SÜD Product Service GmbH, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, GMED SAS, and GMED SAS
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·December 24, 2025
Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer
🇨🇳 China·149 Basic UDI-DIs·149 Devices·3 Importers·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., and UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.
Portable Oxygen Concentrator
Basic UDI-DI
EU MDR
·
Eu Md Class 2b
·Shandong Lovego Industrial Co., Ltd·1 device
HCV ANTIBODY -RT & POC
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Abon Biopharm(Hangzhou) Co., Ltd·On the market
HBSAG - RT & POC
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Abon Biopharm(Hangzhou) Co., Ltd·On the market
Singfiller
Device
EU MDD
·
Eu Md Class 3
·Hangzhou Singclean Medical Products Co., Ltd.·On the market·4 countries
Singfiller
Device
EU MDD
·
Eu Md Class 3
·Hangzhou Singclean Medical Products Co., Ltd.·On the market·4 countries
Singfiller
Device
EU MDD
·
Eu Md Class 3
·Hangzhou Singclean Medical Products Co., Ltd.·On the market·4 countries
Singfiller
Device
EU MDD
·
Eu Md Class 3
·Hangzhou Singclean Medical Products Co., Ltd.·On the market·4 countries
Singfiller
Device
EU MDD
·
Eu Md Class 3
·Hangzhou Singclean Medical Products Co., Ltd.·On the market·4 countries
Singfiller
Device
EU MDD
·
Eu Md Class 3
·Hangzhou Singclean Medical Products Co., Ltd.·On the market·4 countries
Singfiller
Device
EU MDD
·
Eu Md Class 3
·Hangzhou Singclean Medical Products Co., Ltd.·On the market·4 countries
Singfiller
Device
EU MDD
·
Eu Md Class 3
·Hangzhou Singclean Medical Products Co., Ltd.·On the market·4 countries