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STA® - Quality HBPM/LMWH

EUDAMEDFDA UDI

Class C (EU MDR)

Ref 00686

by Diagnostica Stago

Identity

Trade Name
STA® - Quality HBPM/LMWH EUDAMEDFDA UDI
Generic Name
Heparin anti-Xa IVD, control FDA UDI
Device Name
STA® - Quality HBPM/LMWH EUDAMED
Model / Reference
00686 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
03607450006865 EUDAMEDFDA UDI
Basic UDI-DI
3607450CTLS0004QZ EUDAMED
510(k) Number
K010324 FDA UDI
K111822 FDA UDI
FDA Product Code
GGN FDA UDI
EMDN Code
W0103020702 CONTROL PLASMA FOR HAEMOSTASIS EUDAMED
GMDN Term
Heparin anti-Xa IVD, control FDA UDI

Classification

Device Class
Class C 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

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

STA® - Quality HBPM/LMWH by Diagnostica Stago — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Diagnostica Stago
EUDAMED SRN
FR-MF-000017089

Sources (2)

  • EUDAMED b3a8b610-af71-4104-80a1-b2039c19cf59 61 fields · synced Jul 31, 2026
  • FDA UDI 6e3ca3ee-99a6-408d-8c4e-f57d28f34ae3 34 fields · synced May 30, 2026