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Vacuum Erection Device
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref B253Model B239Ref I156Model M106Ref B226Ref B238
Identity
- Trade Name
- Vacuum Erection Device EUDAMEDPos-T-Vac FDA UDI
- Generic Name
- Penile vacuum device FDA UDI
- Device Name
- BOS-2000-3 Twist EUDAMEDMVP-700 EUDAMED
- Model / Reference
- B239 EUDAMEDB253 EUDAMEDM106 EUDAMEDI156 EUDAMEDB226 EUDAMEDB238 EUDAMEDBOS-2000-2 Pump Head FDA UDIBOS-2000-3 Twist Pump Head FDA UDIIVP-600 System FDA UDI
Identifiers
- Catalog Number
- B226 FDA UDIB238 FDA UDII156 FDA UDI
- Primary DI / UDI-DI
- 00656535000055 EUDAMED00656535000734 EUDAMEDFDA UDI00656535000666 EUDAMEDFDA UDI00656535000673 EUDAMEDFDA UDI
- Basic UDI-DI
- 00656535BOS200023B9 EUDAMED0656535PTV67801NYP3 EUDAMED
- Direct Marketing DI
- 00656535000055 EUDAMED00656535000734 EUDAMED00656535000666 EUDAMED00656535000673 EUDAMED
- FDA Product Code
- LKY FDA UDI
- EMDN Code
- U99 DEVICES FOR UROGENITAL SYSTEM - OTHER EUDAMED
- GMDN Term
- Penile vacuum device FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5020 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
FDA UDI
Convenience Kit
No
FDA UDIFDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDIFDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDIFDA UDI
Expiration Date
No
FDA UDIFDA UDI
Manufacturing Date
Yes
FDA UDI
Vacuum Erection Device by Pos-T-Vac LLC — Class IIa — 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 | 00656535BOS200023B9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Pos-T-Vac LLC
- EUDAMED SRN
- US-MF-000025537
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (7)
- EUDAMED f704416b-dd24-43c4-b64f-722b048f5cf4 61 fields · synced Jul 27, 2026
- EUDAMED f433f8c2-015d-4997-94f7-43de1f8eb82c 61 fields · synced May 18, 2026
- FDA UDI d0a0ad90-455d-4ac1-ba2c-f5ffaf9ea941 33 fields · synced May 29, 2026
- FDA UDI 90918a51-8890-4b18-aa4f-aeb0ad5dd11e 33 fields · synced May 30, 2026
- FDA UDI e282af66-0a26-410a-9cc8-e3728da33776 33 fields · synced May 30, 2026
- EUDAMED 8c1b1ad1-ef36-46c6-ab5e-ebeaf8bfff85 61 fields · synced Jul 9, 2026
- EUDAMED 5380901f-b25c-48d0-84eb-47efa65d3bae 61 fields · synced Jul 27, 2026