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Ric5-9-D

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref H48651MSModel RIC5-9-D

by GE Healthcare Austria GmbH & Co OG

Identity

Trade Name
RIC5-9-D EUDAMED
NA FDA UDI
Generic Name
Rectal/vaginal ultrasound imaging transducer FDA UDI
Device Name
RIC5-9-D EUDAMED
Model / Reference
RIC5-9-D EUDAMEDFDA UDI
H48651MS EUDAMED

Identifiers

Primary DI / UDI-DI
00840682108430 EUDAMEDFDA UDI
Basic UDI-DI
8406821BUG00446HQ EUDAMED
Direct Marketing DI
00840682108430 EUDAMED
510(k) Number
K160182 FDA UDI
FDA Product Code
IYO FDA UDI
IYN 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
892.1560 FDA UDI
892.1550 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

Ric5-9-D 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (3)

  • EUDAMED 4718783d-7be8-4764-b1e3-affe82353711 61 fields · synced Oct 7, 2026
  • FDA UDI 5a25f8a2-3df2-4f87-ae03-6a14de65ec72 34 fields · synced May 30, 2026
  • EUDAMED bf373919-ab42-4501-b355-4af94ed03da4 61 fields · synced Jun 20, 2026