Identity
- Trade Name
- Sphere-360™ EUDAMED
- Device Name
- Extension Cable EUDAMED
- Model / Reference
- AFR-00022-C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00199150027613 EUDAMED
- Basic UDI-DI
- 0763000B00026268C EUDAMED
- EMDN Code
- C020180 CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
Sphere-360™ by Medtronic, 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 | 0763000B00026268C | Class I | Active |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
- EUDAMED SRN
- US-MF-000019977
- Authorised Representative
- Medtronic B.V. NL-AR-000006050
Sources (1)
- EUDAMED 81915748-1878-4012-911e-6624a0970b84 61 fields · synced Jul 9, 2026