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Destiny Plus

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref H01000P

by Tcoag ireland ltd

Identity

Trade Name
Destiny Plus EUDAMEDFDA UDI
Generic Name
Coagulation analyser IVD, laboratory FDA UDI
Device Name
Destiny Plus EUDAMED
Model / Reference
H01000P EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
05391521421029 EUDAMEDFDA UDI
Basic UDI-DI
B-05391521421029 EUDAMED
FDA Product Code
JPA FDA UDI
EMDN Code
W0299 IVD INSTRUMENTS - OTHER EUDAMED
GMDN Term
Coagulation analyser IVD, laboratory FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class II FDA UDI
Regulation Number
864.5425 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

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

Yes

EUDAMED

Prescription Use

Yes

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

Destiny Plus by Tcoag ireland ltd — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tcoag ireland ltd
EUDAMED SRN
IE-MF-000027371

Sources (2)

  • EUDAMED 0747ae13-da12-4adc-8f5a-1b619ce44901 61 fields · synced Jun 18, 2026
  • FDA UDI 9ab81f03-ba11-49cd-9896-013c2f2459d4 32 fields · synced May 30, 2026