← Back to catalogue
JADA System
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref JADA-2002
by Organon LLC
Identity
- Trade Name
- JADA System EUDAMEDFDA UDI
- Generic Name
- Intrauterine haemostatic suction catheter FDA UDI
- Device Name
- JADA System EUDAMEDVacuum-induced Hemorrhage Control System FDA UDI
- Model / Reference
- JADA-2002 EUDAMEDFDA UDI
- Description
- Vacuum-induced Hemorrhage Control System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840164527230 EUDAMED00840164527247 EUDAMED00840164521139 FDA UDI
- Basic UDI-DI
- 08401645JADA20K3Q EUDAMED
- 510(k) Number
- K212757 FDA UDI
- FDA Product Code
- OQY FDA UDI
- EMDN Code
- U1099 OBSTETRICS DEVICES - OTHER EUDAMED
- GMDN Term
- Intrauterine haemostatic suction catheter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 884.4530 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
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
JADA System by Organon, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253642 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 08401645JADA20K3Q | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Organon LLC
- EUDAMED SRN
- US-MF-000037903
- Authorised Representative
- Organon Pharma (Ireland) Limited IE-AR-000030118
Sources (4)
- EUDAMED 5b735057-264b-4ef9-9c3b-307b2b5fee8b 61 fields · synced Jul 25, 2026
- EUDAMED f50dc524-9952-460f-b70a-eaef6a10a128 61 fields · synced May 19, 2026
- FDA UDI dc360da0-91a5-4044-b8ff-1eddc611c96b 36 fields · synced May 30, 2026
- FDA 510(k) K253642 1 fields · synced May 29, 2026