STARMag M96 Kit

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref EX00029P

by Seegene

Identity

Trade Name: STARMag™ M96 Kit EUDAMED
STARMag M96 Kit FDA UDI
Generic Name: Nucleic acid extraction/isolation kit IVD FDA UDI
Device Name: STARMag™ M96 Kit EUDAMED
for isolation of nucleic acid from nasopharyngeal swab, oropharyngeal(throat) swab, saliva, sputum, urine, stool, rectal swab, fecal swab, semen, genital swabs (vaginal, cervical, urethral), liquid based cytology (LBC), whole blood and cerebrospinal fluid (CSF) specimen using automated liquid handling instrument FDA UDI
Model / Reference: EX00029P EUDAMED
1 FDA UDI
Description: for isolation of nucleic acid from nasopharyngeal swab, oropharyngeal(throat) swab, saliva, sputum, urine, stool, rectal swab, fecal swab, semen, genital swabs (vaginal, cervical, urethral), liquid based cytology (LBC), whole blood and cerebrospinal fluid (CSF) specimen using automated liquid handling instrument FDA UDI

Identifiers

Catalog Number: EX00029P, EX00030P FDA UDI
Primary DI / UDI-DI: 08809240000281 EUDAMEDFDA UDI
Basic UDI-DI: 924000EX00029G2 EUDAMED
FDA Product Code: JJH FDA UDI
EMDN Code: W0105900101 REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS EUDAMED
GMDN Term: Nucleic acid extraction/isolation kit IVD FDA UDI

Classification

Device Class: Class A EUDAMED
Class I FDA UDI
Regulation Number: 862.2310 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Nucleic acid extraction/isolation kit IVD

STARMag M96 Kit by Seegene — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Nucleic acid extraction/isolation kit IVD.

Whole Blood DNA Extraction Kit (Magnetic Bead Method) — JIANGSU BIOPERFECTUS TECHNOLOGIES CO., LTD. · Class A
abGenix™ Viral DNA and RNA Extraction Kit II (Plate) — AITbiotech Pte Ltd · Class A
Nucleic Acid Extraction Kit — Shandong Bohong Gene Technology Co., Ltd. · Class A
HPLC column — Immundiagnostik AG · Class A
VIRCLIA® EXTRACTION SOLUTION — Vircell, S.L · Class A
ViraSens Total Nucleic Acid Purification Kit — Vitrosens Biotechnology Inc. · Class A
Nucleic Acid Extraction Kit — Bioteke Corporation (Wuxi) Co., Ltd. · Class A
MagPure RNA Kit — Chaozhou Hybribio Biochemistry Ltd. · Class A

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

IVDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	IVDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Seegene

Sources (2)

FDA UDI ae70e94e-2ab5-45e9-8d12-805a48f6cf09 35 fields · synced Jun 19, 2026
EUDAMED 6098d099-0566-4686-8403-5fbdaef63bb3 61 fields · synced Jun 19, 2026