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Tabataba V2

EUDAMEDFDA UDI

Class I (EU MDR)

Ref FF1006Model TABATABA V2

by FIM Medical

Identity

Trade Name
TABATABA V2 EUDAMEDFDA UDI
Generic Name
Carbon monoxide breath analyser FDA UDI
Model / Reference
TABATABA V2 EUDAMED
FF1006 EUDAMED
V2 FDA UDI

Identifiers

Primary DI / UDI-DI
03760253450294 EUDAMEDFDA UDI
Basic UDI-DI
B-03760253450294 EUDAMED
510(k) Number
K080278 FDA UDI
FDA Product Code
CCJ FDA UDI
EMDN Code
V0399 MEASUREMENT DEVICES - OTHER EUDAMED
GMDN Term
Carbon monoxide breath analyser FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
868.1430 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Tabataba V2 by FIM Medical — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FIM Medical
EUDAMED SRN
FR-MF-000017090

Sources (2)

  • EUDAMED f2abacd3-533c-4e8b-81b7-7dbbba5a3d7d 61 fields · synced Aug 2, 2026
  • FDA UDI 291628e3-6278-43a7-9863-e76b5125d76c 34 fields · synced May 30, 2026