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Intercept i2

EUDAMED

Class A (EU MDR)

Ref 1001-0362Model 3001-2661Ref 1001-0498Ref 1001-0383

by OraSure Technologies, Inc.

Identity

Trade Name
Intercept i2 EUDAMED
Device Name
Intercept i2 Oral Fluid Collection Device EUDAMED
Model / Reference
3001-2661 EUDAMED
1001-0362 EUDAMED
1001-0498 EUDAMED
1001-0383 EUDAMED

Identifiers

Primary DI / UDI-DI
10608337000914 EUDAMED
30608337000918 EUDAMED
00608337001006 EUDAMED
Basic UDI-DI
0608337300126127F EUDAMED
Direct Marketing DI
00608337000917 EUDAMED
00608337001006 EUDAMED
EMDN Code
W05019002 SALIVA COLLECTION DEVICES EUDAMED
W050180 SAMPLES COLLECTION DEVICES - OTHER ACCESSORIES EUDAMED

Classification

Device Class
Class A EUDAMED
Market of Registration
Norway EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

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

Intercept i2 by OraSure Technologies, Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
OraSure Technologies, Inc.
EUDAMED SRN
US-MF-000009941
Authorised Representative
QbD RepS BV BE-AR-000000040

Sources (3)

  • EUDAMED 4137facd-9e69-4bb7-8839-b8969390dec2 61 fields · synced Jul 27, 2026
  • EUDAMED 8473b3a8-1842-43e3-9f19-c6ba61fcef4f 61 fields · synced May 17, 2026
  • EUDAMED 287650c4-b1a9-49a5-8f52-0eed4a671264 61 fields · synced May 18, 2026