Identity
- Trade Name
- Vacuum Erection Device EUDAMEDPos-T-Vac FDA UDI
- Generic Name
- Penile vacuum device FDA UDI
- Device Name
- BOS-2000-3 Twist EUDAMED
- Model / Reference
- B239 EUDAMEDBOS-2000-3 Twist System FDA UDI
Identifiers
- Catalog Number
- B239 FDA UDI
- Primary DI / UDI-DI
- 00656535000789 EUDAMEDFDA UDI
- Basic UDI-DI
- 00656535BOS200023B9 EUDAMED
- Direct Marketing DI
- 00656535000789 EUDAMED
- EMDN Code
- U99 DEVICES FOR UROGENITAL SYSTEM - OTHER EUDAMED
- GMDN Term
- Penile vacuum device FDA UDI
Classification
- Device Class
- Class IIa EUDAMED
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA 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 (2)
- EUDAMED 138536d4-d50e-4d0a-848c-cdf501f1688a 61 fields · synced Jun 6, 2026
- FDA UDI fdec7cf0-2bda-43b9-a954-19516525e257 33 fields · synced May 30, 2026