Identity
- Device Name
- VersaTech Bariatric 1100 EUDAMED
- Model / Reference
- V11ULB+-EU-1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07540161720414 EUDAMED
- Basic UDI-DI
- 754016172V11ULB+5N EUDAMED
- EMDN Code
- V08060105,V08060106 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
VersaTech Bariatric 1100 by Usine Rotec Inc — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 754016172V11ULB+5N | Class I | Active |
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Manufacturer
- Manufacturer
- Usine Rotec Inc.
- EUDAMED SRN
- CA-MF-000022549
- Authorised Representative
- International Associates Auditing & Certification Limited IE-AR-000002248
Sources (1)
- EUDAMED b5d99ba0-bab0-4a71-ba40-57aa2f4e81b5 61 fields · synced Jun 18, 2026