Identity
- Trade Name
- Vacuum Erection Device EUDAMEDTimm Medical FDA UDI
- Generic Name
- Penile vacuum device FDA UDI
- Device Name
- Timm Medical UDI-DI EUDAMED
- Model / Reference
- XX50 EUDAMEDEsteem Manual System International FDA UDI
Identifiers
- Catalog Number
- XX50 FDA UDI
- Primary DI / UDI-DI
- 00857312008084 EUDAMEDFDA UDI
- Basic UDI-DI
- 00857312TIMM19034TQ EUDAMED
- Direct Marketing DI
- 00857312008084 EUDAMED
- EMDN Code
- U99 DEVICES FOR UROGENITAL SYSTEM - OTHER EUDAMED
- GMDN Term
- Penile vacuum device FDA UDI
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
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 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 | 00857312TIMM19034TQ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | 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 d898a057-66de-4f74-8fb9-d656f42ae43e 61 fields · synced Jul 30, 2026
- FDA UDI 3870286e-f3a3-49f6-90c1-4acc35b97a2d 33 fields · synced May 24, 2026