Identity
- Trade Name
- BATHMATE HYDROMAX 8 AQUA BLUE EUDAMEDBathmate FDA UDI
- Generic Name
- Penile vacuum device FDA UDI
- Device Name
- Hydropump EUDAMEDBathmate Hydromax 8 Aqua Blue FDA UDI
- Model / Reference
- BM-HM8-AB EUDAMEDHydromax 8 AB FDA UDI
- Description
- Bathmate Hydromax 8 Aqua Blue FDA UDI
Identifiers
- Catalog Number
- BM-HM8-AB FDA UDI
- Primary DI / UDI-DI
- 05060140201014 EUDAMEDFDA UDI
- Basic UDI-DI
- 506014020DXP9J EUDAMED
- FDA Product Code
- LKY FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Penile vacuum device FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5020 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 3 Inch FDA UDIDepth — 8 Inch FDA UDI
Category: Device sterilization/disinfection container, reusable
Bathmate Hydromax 8 Aqua Blue by Dx Products Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506014020DXP9J | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DX Products Limited
- EUDAMED SRN
- GB-MF-000014264
- Authorised Representative
- Care Surgical Supplies Limited IE-AR-000001724
Sources (2)
- EUDAMED a874be71-1a3c-49aa-bffd-ebefce8069c7 61 fields · synced Jun 18, 2026
- FDA UDI 24e4fa83-01fa-4c00-930c-257bab429c1e 36 fields · synced May 30, 2026