FDA.report

Minvitro Embryo Transfer Catheter

Primary DI
06971855770926
Company
Guangzhou Hehong Biotech Co., Ltd.
Model
ETCB20175-C
Catalog number
ETCB20175-C
Published
2026-03-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
419557208
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
06971855770926PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
06971855770926PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
MQFCatheter, Assisted Reproduction2Obstetrics/Gynecology884.6110NEligible

Premarket Submissions

SubmissionSupplement
K253354000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K253354000Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C)Guangzhou Hehong Biotech Co., Ltd.2026-02-12MQF

GMDN Terms

TermDefinition
Assisted reproduction transfer catheter/setA device or collection of devices that includes a flexible polymer tube intended to be used primarily to transfer gametes (eggs or sperm) and/or embryos into the female reproductive tract for the purpose of assisted reproduction [e.g., intrauterine insemination (IUI) or gamete intrafallopian transfer (GIFT)]. In addition to the ‘live transfer’ catheter it may also include a trial transfer catheter intended to assess/ensure that embryo placement will be successful; it typically also includes devices intended to assist catheter introduction (e.g., outer guide sheath, stylet). This is a single-use device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

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06971855770315Minvitro Vitrification StrawMVT-VSNYMVT-VSNY2026-03-10
06971855770322Minvitro Vitrification StrawMVT-VSNBMVT-VSNB2026-03-10
06971855770339Minvitro Vitrification StrawMVT-VSNGMVT-VSNG2026-03-10
06971855770377Minvitro Vitrification StrawMVT-VSNPMVT-VSNP2026-03-10
06971855770902Minvitro Embryo Transfer CatheterETCB20175ETCB201752026-03-10
06971855770919Minvitro Embryo Transfer CatheterETCA23175ETCA231752026-03-10
06971855770933Minvitro Embryo Transfer CatheterETCA23175-CETCA23175-C2026-03-10
06971855770940Minvitro Embryo Transfer CatheterETCB20175-ETETCB20175-ET2026-03-10
06971855770957Minvitro Embryo Transfer CatheterETCB20175-ET-CETCB20175-ET-C2026-03-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06971855770902Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.MQF2026-03-10
06971855770919Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.MQF2026-03-10
06971855770933Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.MQF2026-03-10
06971855770940Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.MQF2026-03-10
06971855770957Minvitro Embryo Transfer CatheterGuangzhou Hehong Biotech Co., Ltd.MQF2026-03-10
14580745043782ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
14580745043904ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
14580745044239ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
14580745044246ET CATHETER RYDENKITAZATO CORPORATIONMQF2025-09-17
14580745043775ET CatheterKITAZATO CORPORATIONMQF2024-09-09
14580745043898ET CatheterKITAZATO CORPORATIONMQF2024-09-09
14580745044260ET CatheterKITAZATO CORPORATIONMQF2024-09-09
14580745044284ET CatheterKITAZATO CORPORATIONMQF2024-09-09
06971982050328VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdMQF2024-08-26
06971982050335VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdMQF2024-08-26
06971982050342VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdMQF2024-08-26
06971982051066VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdMQF2024-08-26
06971982051073VitaVitroShenzhen Vitavitro Bio-Tech Co.,LtdMQF2024-08-26
M803TMI1290Embryo Transfer Catheter MEDGYN PRODUCTS, INC.MQF2024-01-03
03700111425026FRYDMAN® CLASSIC 4.5LABORATOIRE CCDMQF2023-12-05
03700111425033FRYDMAN® CLASSIC 5.5LABORATOIRE CCDMQF2023-12-05
03700111425040FRYDMAN ® SOFT WITH GUIDELABORATOIRE CCDMQF2023-12-05
03700111425064T.D.T.®SETLABORATOIRE CCDMQF2023-12-05
03700111425088INVENTCATH ECOLABORATOIRE CCDMQF2023-12-05
03700111425095STYLET FOR FRYDMAN® ULTRASOFT & FRYDMAN® ULTRASOFT echoLABORATOIRE CCDMQF2023-12-05
03700111425101CLASSIC ULTRASOFT 18 CMLABORATOIRE CCDMQF2023-12-05
03700111425125ULTRASOFT FRYDMAN ® SET ECHO WITH GUIDELABORATOIRE CCDMQF2023-12-05
03700111425132MOCK CATHETERLABORATOIRE CCDMQF2023-12-05
03700111425149CLASSIC ULTRASOFT MOCK 18 CMLABORATOIRE CCDMQF2023-12-05
03700111425194ULTRASOFT FRYDMAN ® SET ECHOLABORATOIRE CCDMQF2023-12-05