Identity
- Device Name
- Versatech 1100 ULB with Scale EUDAMED
- Model / Reference
- V11ULB-xx-1000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B303D035 EUDAMED
- Basic UDI-DI
- ++B303D035XV EUDAMED
- EMDN Code
- V08060105,V08060106 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland 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 1100 ULB with Scale 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 | ++B303D035XV | 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 a93eaced-5d3b-4bcd-8908-432da2d1365b 61 fields · synced Jul 12, 2026