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Koala Intrauterine Pressure Catheter

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref IPC-5000E

by Clinical Innovations, LLC

Identity

Trade Name
Koala Intrauterine Pressure Catheter EUDAMED
Koala® FDA UDI
Generic Name
Intrapartum pressure monitoring catheter FDA UDI
Device Name
Koala Intrauterine Pressure Catheter EUDAMED
Koala® Intrauterine Pressure Catheter with external balloon FDA UDI
Model / Reference
IPC-5000E EUDAMEDFDA UDI
Description
Koala® Intrauterine Pressure Catheter with external balloon FDA UDI

Identifiers

Primary DI / UDI-DI
00814247020178 EUDAMEDFDA UDI
Basic UDI-DI
0814247005000RG EUDAMED
510(k) Number
K974389 FDA UDI
FDA Product Code
HFN FDA UDI
EMDN Code
U100199 OBSTETRICAL CATHETERS - OTHER EUDAMED
GMDN Term
Intrapartum pressure monitoring catheter FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
884.2700 FDA UDI
Market of Registration
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Koala Intrauterine Pressure Catheter by Clinical Innovations, LLC — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Clinical Innovations, LLC
EUDAMED SRN
US-MF-000031386
Authorised Representative
MVF FR-AR-000011189

Sources (3)

  • EUDAMED 250e22d4-5f5d-4e86-8e67-7cec4536a61f 61 fields · synced Jul 9, 2026
  • FDA UDI bd6a239c-61b9-4d07-a54c-2f70e1bd410b 34 fields · synced May 30, 2026
  • FDA 510(k) K250897 1 fields · synced May 18, 2026