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Ric5-9a-Rs

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref H48701EJModel RIC5-9A-RS

by GE Healthcare Austria GmbH & Co OG

Identity

Trade Name
RIC5-9A-RS EUDAMED
NA FDA UDI
Generic Name
Rectal/vaginal ultrasound imaging transducer FDA UDI
Device Name
RIC5-9A-RS EUDAMED
Model / Reference
RIC5-9A-RS EUDAMEDFDA UDI
H48701EJ EUDAMED

Identifiers

Primary DI / UDI-DI
00840682108553 EUDAMEDFDA UDI
Basic UDI-DI
8406821BUG00442HG EUDAMED
Direct Marketing DI
00840682108553 EUDAMED
510(k) Number
K160162 FDA UDI
K160184 FDA UDI
FDA Product Code
IYN FDA UDI
IYO FDA UDI
ITX FDA UDI
EMDN Code
Z1104020202 ENDOCAVITARY ULTRASOUND PROBES, MULTIDIMENSIONAL EUDAMED
GMDN Term
Rectal/vaginal ultrasound imaging transducer FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
892.1550 FDA UDI
892.1560 FDA UDI
892.1570 FDA UDI
Market of Registration
Austria 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

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

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

Ric5-9a-Rs by GE Healthcare Austria GmbH & Co OG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
GE Healthcare Austria GmbH & Co OG
EUDAMED SRN
AT-MF-000001461

Sources (3)

  • EUDAMED 482f6679-5c1b-474b-a44f-45279b320ffb 61 fields · synced Oct 6, 2026
  • FDA UDI 6ba9399c-0d1c-4b30-bbfc-1d51995abb44 34 fields · synced May 30, 2026
  • EUDAMED b0ec9f8f-fbf1-4677-bceb-a546f5dbdfb1 61 fields · synced Jul 16, 2026