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Shenzhen Vitavitro Bio-Tech Co., Ltd.

China · Shenzhen

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 0Class II 7Class III 0

plus 9 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States9 registration records, 6 510(k), 0 PMA

Manufacturer names merged into this page: Shenzhen VitaVitro Biotech Co.,Ltd.

FDA 510(k) clearances by year

12018 · K180073

12019 · K191063

12020 · K200408

12022 · K212410

22024 · K240523

FDA listed device types

Needle, Assisted Reproduction 1Media, Reproductive, Exempt 1Catheter, Assisted Reproduction 1Media, Reproductive 1Microtools, Assisted Reproduction (Pipettes), Exempt 1Labware, Assisted Reproduction 1Labware, Assisted Reproduction, Exempt 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K240523	VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)	2024-11-15
US	K240307	VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH)	2024-08-16
US	K212410	VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium	2022-02-01

Shenzhen Vitavitro Bio-Tech Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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