Sinapi Biomedical (Pty) , Ltd.

South Africa ZA-MF-000012126 Last updated 22 Oct 2026

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Devices: 9
Registries: EUDAMEDFDA 510(k)FDA
FDA recalls: 0

Catalogue9

Ellavi UBT Ref UBT-D

Class IIa EUDAMED Active
ELLAVI Drape Ref BC01

Class I EUDAMED Active
Sinapi Chest Drain Ref XL200S

Class I EUDAMED Active
Sinapi Chest Drain Ref XL1000SC

Class I EUDAMED Active
Sinapi Chest Drain Ref XL200SC

Class I EUDAMED Active
Sinapi Chest Drain Ref XL2200S

Class I EUDAMED Active
Sinapi Chest Drain Ref XS100

Class I EUDAMED Active
Sinapi Chest Drain Ref XS50-D

Class I EUDAMED Active
Sinapi Chest Drain Ref XL2000S

Class I EUDAMED Active
Sinapi urimeter Ref SUM500V2

Class I EUDAMED Active
Sinapi Chest Drain Ref XL2200SD

Class I EUDAMED Active
Sinapi Chest Drain Ref XL1150Si

Class I EUDAMED Active
Sinapi Collection container Ref D001

Class I EUDAMED Active
SINAPI Collection Container Ref D1150

Class I EUDAMED Active
Sinapi Chest Drain Ref XL1000S

Class I EUDAMED Active
Sinapi Chest Drain Ref XL2000SD

Class I EUDAMED Active
Sinapi Chest Drain Ref XL1150SCi

Class I EUDAMED Active
Sinapi Chest Drain Ref XL1150SCiW

Class I EUDAMED Active
Sinapi Chest Drain Ref XS100D

Class I EUDAMED Active
Ellavi Ubt Ref K230849

Class II FDA 510(k) Active

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

Notified body 1639 1 certificate

ES23/00000108 Supplemented

Quality management system EU MDR

Issued
1 Apr 2026

Expires
28 Feb 2028

Reason
Add device or group

Notified bodies

Notified body 1639

FDA establishments1

Registered with the FDA under this company group, matched by name.

Sinapi Biomedical (Pty) Ltd Stellenbosch Western Cape · ZA FEI 3008388005

What Sinapi Biomedical (Pty) , Ltd. makes

Sinapi Biomedical (Pty) Ltd. manufactures the ELLAVI UBT, a device used for uterine biopsy procedures to diagnose abnormal uterine bleeding.

The ELLAVI UBT is classified as a Class II medical device and is listed under the FDA’s 510(k) pathway. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: South Africa
Address: 3, Lelie Road, Stellenbosch, South Africa
Website: www.sinapibiomedical.com
Email: [email protected]
PRRC contact: Lisa Kruger
EUDAMED SRN: ZA-MF-000012126

Catalogue9

Ellavi UBT Ref UBT-D

ELLAVI Drape Ref BC01

Sinapi Chest Drain Ref XL200S

Sinapi Chest Drain Ref XL1000SC

Sinapi Chest Drain Ref XL200SC

Sinapi Chest Drain Ref XL2200S

Sinapi Chest Drain Ref XS100

Sinapi Chest Drain Ref XS50-D

Sinapi Chest Drain Ref XL2000S

Sinapi urimeter Ref SUM500V2

Sinapi Chest Drain Ref XL2200SD

Sinapi Chest Drain Ref XL1150Si

Sinapi Collection container Ref D001

SINAPI Collection Container Ref D1150

Sinapi Chest Drain Ref XL1000S

Sinapi Chest Drain Ref XL2000SD

Sinapi Chest Drain Ref XL1150SCi

Sinapi Chest Drain Ref XL1150SCiW

Sinapi Chest Drain Ref XS100D

Ellavi Ubt Ref K230849