Identity
- Trade Name
- REBOA EUDAMEDREBOA Catheter FDA UDI
- Generic Name
- Intravascular occluding balloon catheter, image-guided FDA UDI
- Device Name
- REBOA EUDAMEDA coaxial catheter recommended for temporary occlusion of the aorta. FDA UDI
- Model / Reference
- 362 EUDAMEDFDA UDIRB203050 EUDAMED
- Description
- A coaxial catheter recommended for temporary occlusion of the aorta. FDA UDI
Identifiers
- Catalog Number
- RB203050 FDA UDI
- Primary DI / UDI-DI
- D-10887714022040NH EUDAMED10887714024617 FDA UDI
- Basic UDI-DI
- B-10887714022040NH EUDAMED
- 510(k) Number
- K160598 FDA UDI
- FDA Product Code
- MJN FDA UDI
- EMDN Code
- C0104020103 VASCULAR OCCLUSION CATHETERS EUDAMED
- GMDN Term
- Intravascular occluding balloon catheter, image-guided FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4450 FDA UDI
- Market of Registration
- Norway 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Ethylene Oxide FDA UDI
Reboa by NuMED, Inc. — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10887714022040NH | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NuMED, Inc.
- EUDAMED SRN
- US-MF-000010948
- Authorised Representative
- G. van Wageningen B.V. NL-AR-000010437
Sources (2)
- EUDAMED b9f6af09-72fc-4421-95e7-6e21e0fa90e6 61 fields · synced Jun 8, 2026
- FDA UDI 2e8321d8-c1b3-47a8-bb3c-49817ada48e0 36 fields · synced May 30, 2026