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Paradise™
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref PRDS-USG-2XRef PRDS-068-02Ref PRDS-067-02Ref PRDS-066-02Ref PRDS-064-02Ref PRDS-063-02
Identity
- Trade Name
- Paradise™ EUDAMEDParadise® Catheter FDA UDIParadise® Generator FDA UDI
- Generic Name
- Renal denervation ultrasound system catheter FDA UDIRenal denervation ultrasound system generator FDA UDI
- Device Name
- Paradise Generator with Paradise Remote EUDAMEDParadise Catheter 8mm EUDAMEDParadise Generator EUDAMEDParadise Catheter 7mm EUDAMEDParadise Catheter 6mm EUDAMEDParadise Catheter 4.2mm EUDAMEDParadise Catheter 3.5mm EUDAMEDPRDS-067-02 Paradise® Catheter 7mm FDA UDIPRDS-064-02 Paradise® Catheter 4.2mm FDA UDIPRDS-USG-2X Paradise® Generator FDA UDIPRDS-063-02 Paradise® Catheter 3.5mm FDA UDIPRDS-066-02 Paradise® Catheter 6mm FDA UDIPRDS-068-02 Paradise® Catheter 8mm FDA UDIPRDS-USG-2X Paradise® Generator with Paradise® Remote FDA UDI
- Model / Reference
- PRDS-USG-2X EUDAMEDFDA UDIPRDS-067-02 EUDAMEDFDA UDIPRDS-064-02 EUDAMEDFDA UDIPRDS-063-02 EUDAMEDFDA UDIPRDS-066-02 EUDAMEDFDA UDIPRDS-068-02 EUDAMEDFDA UDI
- Description
- PRDS-067-02 Paradise® Catheter 7mm FDA UDIPRDS-064-02 Paradise® Catheter 4.2mm FDA UDIPRDS-USG-2X Paradise® Generator FDA UDIPRDS-063-02 Paradise® Catheter 3.5mm FDA UDIPRDS-066-02 Paradise® Catheter 6mm FDA UDIPRDS-068-02 Paradise® Catheter 8mm FDA UDIPRDS-USG-2X Paradise® Generator with Paradise® Remote FDA UDI
Identifiers
- Catalog Number
- PRDS-067-02 FDA UDIPRDS-064-02 FDA UDIPRDS-USG-2X FDA UDIPRDS-063-02 FDA UDIPRDS-066-02 FDA UDIPRDS-068-02 FDA UDI
- Primary DI / UDI-DI
- 00810008950128 EUDAMEDFDA UDI00810008950036 EUDAMEDFDA UDI00810008950005 EUDAMEDFDA UDI00810008950111 EUDAMEDFDA UDI00810008950067 EUDAMEDFDA UDI00810008950029 EUDAMEDFDA UDI00810008950043 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00810008950128 EUDAMEDB-00810008950043 EUDAMEDB-00810008950111 EUDAMEDB-00810008950036 EUDAMEDB-00810008950029 EUDAMEDB-00810008950005 EUDAMEDB-00810008950067 EUDAMED
- PMA Number
- P220023 FDA UDI
- FDA Product Code
- QYI FDA UDI
- EMDN Code
- Z129099 VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - OTHER EUDAMEDK02050109 COMBINED RADIOFREQUENCY / ULTRASONIC SURGERY HANDPIECES, SINGLE-USE EUDAMED
- GMDN Term
- Renal denervation ultrasound system catheter FDA UDIRenal denervation ultrasound system generator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass III FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
Yes
FDA UDIFDA 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 UDIFDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDIFDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Balloon Diameter — 7 Millimeter FDA UDIBalloon Diameter — 4.2 Millimeter FDA UDIBalloon Diameter — 3.5 Millimeter FDA UDIBalloon Diameter — 6 Millimeter FDA UDIBalloon Diameter — 8 Millimeter FDA UDI
Category: Fixture/appliance dental drill bit, reusable
Paradise™ by Recor Medical, Inc. — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00810008950128 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-00810008950128 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- ReCor Medical, Inc.
- EUDAMED SRN
- US-MF-000027816
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (14)
- EUDAMED 156634a8-59e5-4ed2-ba54-31d51c528081 61 fields · synced Sep 17, 2026
- FDA UDI 471fd0e5-dd6e-4abb-aebd-6c1948378e1d 38 fields · synced May 25, 2026
- FDA UDI b1a92d95-4b2c-4af5-a94d-c0a1795eeb2f 38 fields · synced May 25, 2026
- FDA UDI 62395382-fae2-4713-b7ff-e435b39cccbb 37 fields · synced May 29, 2026
- FDA UDI c56a70b4-6260-4b4e-90a7-57fd0f809f11 38 fields · synced May 30, 2026
- FDA UDI b9a7a088-6496-4924-b173-cdd8cc685ed6 38 fields · synced May 30, 2026
- FDA UDI 920913bf-e5d8-4369-b76e-7d365106eb2d 38 fields · synced May 30, 2026
- FDA UDI f2134098-6918-467e-80a5-6b7b1e8867af 37 fields · synced May 30, 2026
- EUDAMED b04c19cf-6d9d-4832-bdf1-5f0f0254f568 61 fields · synced Jun 20, 2026
- EUDAMED 3cd990b1-f1e9-434d-92f5-bb4692eb64bc 61 fields · synced Jul 8, 2026
- EUDAMED 51c187c8-6e9d-4d79-9778-33b3541ca562 61 fields · synced Jul 12, 2026
- EUDAMED 666101be-cfa1-4878-843c-dad95e468f06 61 fields · synced Jul 15, 2026
- EUDAMED ffcdd3a7-6eef-45cc-862d-0a5d6e73d077 61 fields · synced Jul 17, 2026
- EUDAMED c13f92b0-2b03-45f0-a04c-073becbf9544 61 fields · synced Jul 25, 2026