Identity
- Trade Name
- SIRA-1000 EUDAMED
- Device Name
- SIRA RFA Electrosurgical Device EUDAMED
- Model / Reference
- SIRA-1000 EUDAMED2050240 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00861841000204 EUDAMED
- Basic UDI-DI
- B-00861841000204 EUDAMED
- EMDN Code
- K02010199 MONO- AND BIPOLAR INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sira-1000 by Innoblative Designs, Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00861841000204 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Innoblative Designs, Inc.
- EUDAMED SRN
- US-MF-000044282
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (1)
- EUDAMED 04660c6f-f1b0-4620-b581-01524a67e04a 61 fields · synced Jun 19, 2026