Identity
- Trade Name
- Prytime Medical Devices Inc. FDA UDI
- Generic Name
- Intravascular occluding balloon catheter, image-guided FDA UDI
- Device Name
- ER-REBOA™ PLUS Catheter EUDAMEDER-REBOA Plus Balloon Occlusion Catheter FDA UDI
- Model / Reference
- ER7232PLUS-EU EUDAMEDER7232PLUS FDA UDI
- Description
- ER-REBOA Plus Balloon Occlusion Catheter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850001105057 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00850001105057 EUDAMED
- 510(k) Number
- K193440 FDA UDI
- FDA Product Code
- DQO FDA UDIDQY FDA UDIMJN FDA UDI
- EMDN Code
- C019009 AORTIC OCCLUSION SYSTEMS EUDAMED
- GMDN Term
- Intravascular occluding balloon catheter, image-guided FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1200 FDA UDI870.1250 FDA UDI870.4450 FDA UDI
- Market of Registration
- Netherlands 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
Yes
FDA UDI
ER-REBOA™ PLUS Catheter by Prytime Medical Devices 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-00850001105057 | 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
- Prytime Medical Devices Inc.
- EUDAMED SRN
- US-MF-000008225
- Authorised Representative
- MPS Medical Product Service GmbH DE-AR-000005009
Sources (2)
- EUDAMED 1c6496bd-591e-4524-915a-f312b7b3433b 61 fields · synced Oct 6, 2026
- FDA UDI f519235e-263c-459e-9670-861d59965f69 35 fields · synced May 30, 2026