SAFECARE BIOTECH(HANGZHOU)CO.,LTD

FDA Device Registration & Listing · Huzhou Zhejiang, CN · Registration 3013077867

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013077867
FEI Number
3013077867
Entity Name
SAFECARE BIOTECH(HANGZHOU)CO.,LTD
City/State/Country
Huzhou Zhejiang, CN
Establishment Address
No.689, Changxing Avenue, Taihu Street,, Changxing County, Huzhou Zhejiang 313100, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Safecare Biotech(Hangzhou)Co.,Ltd (Owner Number: 10052102)
Owner / Operator Contact Address
Building 2/203 No.18 Haishu Rd.,, Cangqian Sub-district,Yuhang District, Hangzhou, CN-ZJ 311121, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Safecare Urinary Tract Infection Test Cubtale Ovulation (LH) Test Strip SAFECARE Luteinizing Hormone Rapid Test Midstream SAFECARE Luteinizing Hormone Rapid Test Strip SAFECARE Luteinizing Hormone Rapid Test Device TTestahead Luteinizing Hormone Rapid Test Device Welcheck Luteinizing Hormone Rapid Test Strip Welcheck Luteinizing Hormone Rapid Test Midstream FIRSTVIEW Luteinizing Hormone Rapid Test Midstream FIRSTVIEW Luteinizing Hormone Rapid Test Strip Unicare Luteinizing Hormone Rapid Test Strip Unicare Luteinizing Hormone Rapid Test Midstream FIRSTVIEW Luteinizing Hormone Rapid Test Device Wholesome Story Ovulation(LH) Test Strip TTestahead Luteinizing Hormone Rapid Test Strip TTestahead Luteinizing Hormone Rapid Test Midstream Welcheck Luteinizing Hormone Rapid Test Device Unicare Luteinizing Hormone Rapid Test Device hCG Urine Test Midstream hCG Urine Test Cassette hCG Urine Test Strip Safecare FYL Urine Test Cassette Safecare Fentanyl Urine Test Cassette FIRSTVIEW FYL Urine Test Cassette FIRSTVIEW Fentanyl Urine Test Cassette Firstview urinary tract infection Test Ttestahead urinary tract infection Test WelCheck Urinary Tract Infection Test Safecare urinary tract infection Test Firstview Vaginal PH Rapid Test Cassette TTestahead Vaginal PH Rapid Test Cassette WelCheck Vaginal pH Rapid Test Cassette Exploro Vaginal Health pH Test Device 2San Vaginal pH Rapid Test Cassette Safecare Vaginal PH Rapid Test Cassette Unicare Vaginal PH Rapid Test Cassette Cwhole Vaginal PH Rapid Test Cassette SAFECARE Multi-Drug Urine Test Cup SAFECARE Multi-Drug Urine Test Dip Card Safecare EDDP Urine Test Dipcard Safecare BUP Urine Test Dipcard Safecare OXY Urine Test Dipcard Safecare MDMA Urine Test Dipcard SAFECARE® Multi-Drug Urine Test Cup SAFECARE® Multi-Drug Urine Test Dip Card Safecare Multi-Drug Urine Test Dip Card Safecare Multi-Drug Urine Test Cup SAFECARE Multi-Drug Urine Test DipCard SAFECARE Multi-Drug Urine Test Cup SAFECARE COT Saliva Cup Test SAFECARE COT Urine Cassette Test SAFECARE COT Urine Dip card Test SAFECARE COT Saliva Dip Card Test SAFECARE COT Saliva Cassette Test SAFECARE COT Urine Strip Test FIRSTVIEW COT Urine Strip Test EXPLORO Highly Sensitive NICOTINE URINE TEST FIRSTVIEW COT Saliva Cup Test FIRSTVIEW COT Saliva Dip Card Test TTestahead Cotinine(COT) Urine Test Dipcard FIRSTVIEW COT Urine Cassette Test FIRSTVIEW COT Saliva Cassette Test TTestahead COT Urine Strip Test FIRSTVIEW COT Urine Dip card Test TTestahead COT Saliva Cup Test UNICARE COT Saliva Dip Card Test Welcheck COT Saliva Cassette Test Welcheck COT Saliva Cup Test Welcheck COT Urine Strip Test Welcheck COT Saliva Dip Card Test TTestahead COT Urine Cassette Test UNICARE COT Urine Strip Test TTestahead COT Saliva Dip Card Test Welcheck COT Urine Dip card Test TTestahead COT Urine Dip card Test UNICARE COT Saliva Cup Test UNICARE COT Urine Cassette Test Welcheck COT Urine Cassette Test UNICARE COT Urine Dip card Test TTestahead COT Saliva Cassette Test UNICARE COT Saliva Cassette Test

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2025-01-20
JMT Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) Clinical Chemistry Class 1 862.1510 2025-01-20
NGE Test, Luteinizing Hormone (Lh), Over The Counter Clinical Chemistry Class 1 862.1485 2019-09-21
LCX Kit, Test, Pregnancy, Hcg, Over The Counter Clinical Chemistry Class 2 862.1155 2020-09-15
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2024-06-26
LJX Test, Urine Leukocyte Hematology Class 1 864.7675 2023-11-23
LNW Paper, Obstetric Ph Clinical Chemistry Class 1 862.1550 2023-08-21
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2020-09-18
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2020-09-18
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2020-09-18
NGI Test, Morphine, Over The Counter Clinical Toxicology Class 2 862.3640 2020-09-18
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2020-09-18
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2020-09-18
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2020-09-18
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2020-09-18
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2020-09-18
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2020-09-18
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2020-09-18
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2020-09-18
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2021-10-27
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2021-10-27
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2021-10-27
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2021-10-27
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2021-10-27
NGI Test, Morphine, Over The Counter Clinical Toxicology Class 2 862.3640 2021-10-27
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2021-10-27
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2021-10-27
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2021-10-27
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2021-10-27
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2021-10-27
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2021-10-27
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2018-09-19
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2018-09-19
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2018-09-19
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2018-09-19
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2018-09-19
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2018-09-19
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2018-09-19
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2018-09-19
NFY Test, Cocaine And Cocaine Metabolites, Over The Counter Clinical Toxicology Class 2 862.3250 2018-11-28
NGM Test, Phencyclidine (Pcp), Over The Counter Unknown Class U N/A 2018-11-28
QBF Test, Propoxyphene, Over The Counter Clinical Toxicology Class 2 862.3700 2018-11-28
NFT Test, Amphetamine, Over The Counter Clinical Toxicology Class 2 862.3100 2018-11-28
PTG Test, Methadone, Over The Counter Clinical Toxicology Class 2 862.3620 2018-11-28
NFW Test, Cannabinoid, Over The Counter Clinical Toxicology Class 2 862.3870 2018-11-28
PTH Test, Barbiturate, Over The Counter Clinical Toxicology Class 2 862.3150 2018-11-28
NGL Test, Opiates, Over The Counter Clinical Toxicology Class 2 862.3650 2018-11-28
NGI Test, Morphine, Over The Counter Clinical Toxicology Class 2 862.3640 2018-11-28
NFV Test, Benzodiazepine, Over The Counter Clinical Toxicology Class 2 862.3170 2018-11-28
QAW Test, Tricyclic Antidepressants, Over The Counter Clinical Toxicology Class 2 862.3910 2018-11-28
NGG Test, Methamphetamine, Over The Counter Clinical Toxicology Class 2 862.3610 2018-11-28
MRS Test System, Nicotine, Cotinine, Metabolites Clinical Toxicology Class 1 862.3220 2022-02-09

Official Correspondent

Alex Qiu

US Agent Details

Joe Xia Email: jxia@lsi-consulting.org Phone: (301) 2500831

Related Public Records

Same Entity

Safecare Biotech(Hangzhou)Co.,Ltd
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K964108 Direct Access Diagnostics FACT PLUS PREGNANCY TEST 1996-11-18
K945514 Princeton BioMeditech Corp. LIFESIGN(TM) 1, BIOSIGN(TM) 1, LIFESIGN PLUS(TM), LIFESIGN(TM) HCG 1995-02-10
K150022 Guangzhou Wondfo Biotech Co., Ltd. Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream 2015-08-07
K043443 Guangzhou Wondfo Biotech Co., Ltd. ONE STEP HCG URINE PREGNANCY TEST 2005-04-08
K173229 Guangzhou Wondfo Biotech Co., Ltd. Preview Digital Pregnancy Test 2018-03-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0043-2024 Universal Meditech Inc. 1
One Step Ovulation Test REF 200-01
Z-0042-2024 Universal Meditech Inc. 2
One Step Pregnancy Test REF 100-01
Z-0027-04 Instrumentation Laboratory Co. 1
Lactate Disposable Membrane Caps Product Number: 0018108400

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013077867. Last updated year: 2026. Please use registration number 3013077867 when referencing this establishment in official correspondence.
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