Nucleic acid extraction reagent (FFPE TNA)

EUDAMEDFDA UDI

Class A (EU MDR)

Ref N/ARef 11107Model FFPE TNA-B1、FFPE TNA-B2、FFPE TNA-P1、FFPE TNA-P2Ref 11108Ref 11106

by TargetingOne Technology (Beijing) Corporation

Identity

Trade Name: Nucleic acid extraction reagent (FFPE TNA) EUDAMED
TARGETINGONE FDA UDI
Generic Name: Nucleic acid extraction/isolation kit IVD FDA UDI
Device Name: N/A EUDAMED
Nucleic acid extraction reagent (FFPE TNA) EUDAMED
"Model: FFPE TNA-B2, Specification: 64 tests/box" FDA UDI
"Model: FFPE TNA-P1, Specification: 64 tests/box" FDA UDI
Model / Reference: N/A EUDAMED
FFPE TNA-B1、FFPE TNA-B2、FFPE TNA-P1、FFPE TNA-P2 EUDAMED
11107 EUDAMED
11108 EUDAMED
11106 EUDAMED
Nucleic acid extraction reagent (FFPE TNA)/FFPE TNA-B2 FDA UDI
Nucleic acid extraction reagent (FFPE TNA)/FFPE TNA-P1 FDA UDI
Description: "Model: FFPE TNA-B2, Specification: 64 tests/box" FDA UDI
"Model: FFPE TNA-P1, Specification: 64 tests/box" FDA UDI

Identifiers

Primary DI / UDI-DI: 06974689625028 EUDAMED
06974689624045 EUDAMEDFDA UDI
06974689624052 EUDAMEDFDA UDI
Basic UDI-DI: 697468962502S4 EUDAMED
FDA Product Code: PEG FDA UDI
EMDN Code: W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER 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: Belgium EUDAMED
Austria EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

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

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

Nucleic acid extraction reagent (FFPE TNA) by TargetingOne Technology (Beijing) Corporation — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID

Similar devices

Also classified as Nucleic acid extraction/isolation kit IVD.

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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 Active

CE/IVDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDR	697468962502S4	Class A	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class A	Pending data

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Manufacturer

Manufacturer: TargetingOne Technology (Beijing) Corporation
EUDAMED SRN: CN-MF-000028247
Authorised Representative: SUNGO Europe B.V. NL-AR-000000247

Sources (6)

EUDAMED 0a5a1979-1ce5-4a75-96fb-ba8bcb247ac9 61 fields · synced Jul 19, 2026
FDA UDI 180b96eb-6792-4445-b2f5-3df16dae41f2 33 fields · synced May 30, 2026
FDA UDI c22caed3-739c-414a-8521-263dd3ac0284 33 fields · synced May 30, 2026
EUDAMED 7e07fd13-e648-4233-91b4-5cde9569f001 61 fields · synced Jul 9, 2026
EUDAMED 7a636da4-c5a7-4d58-823b-ef402d617f53 61 fields · synced Jul 13, 2026
EUDAMED ed4796d8-195d-4959-8e63-77efc400a55f 61 fields · synced Jul 19, 2026