Identity
- Trade Name
- BATHMATE HYDROMAX 8 BRILLIANT RED EUDAMEDBathmate FDA UDI
- Generic Name
- Penile vacuum device FDA UDI
- Device Name
- Hydropump EUDAMEDBathmate Hydromax 8 Brilliant Red FDA UDI
- Model / Reference
- BM-HM8-BR EUDAMEDHydromax 8 BR FDA UDI
- Description
- Bathmate Hydromax 8 Brilliant Red FDA UDI
Identifiers
- Catalog Number
- BM-HM8-BR FDA UDI
- Primary DI / UDI-DI
- 05060140201038 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
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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 3 Inch FDA UDIDepth — 8 Inch FDA UDI
Bathmate Hydromax 8 Brilliant Red by Dx Products Limited — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 d5c3c5f1-3873-4124-ac7b-17a359ae5b07 61 fields · synced Jun 17, 2026
- FDA UDI 788f11dd-9b6d-4a0f-9eaf-35a9f00d0992 36 fields · synced May 30, 2026