← Back to catalogue
ECT Cotton Bite Blocks Size Large
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 9391-0003 L
by Mecta Llc
Identity
- Device Name
- ECT Cotton Bite Blocks Size Large EUDAMED
- Model / Reference
- 9391-0003 L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10860007792509 EUDAMED
- Basic UDI-DI
- 10860007792509GE EUDAMED
- EMDN Code
- Z12109002 ELECTROCONVULSIVE THERAPY (ECT) EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ECT Cotton Bite Blocks Size Large by Mecta Llc — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union No Longer Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201309 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 10860007792509GE | Class I | No Longer Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mecta Llc
- EUDAMED SRN
- US-MF-000019538
- Authorised Representative
- ICON (LR) Limited IE-AR-000006507
Sources (2)
- EUDAMED ac512f93-79b4-4b79-89e9-9069b897fbaa 61 fields · synced Jun 18, 2026
- FDA 510(k) K201309 1 fields · synced May 18, 2026