Identity
- Trade Name
- Prism-1 Mapping System EUDAMED
- Device Name
- Prism-1 Mapping System EUDAMED
- Model / Reference
- AFR-00003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B938AFR000030 EUDAMED
- Basic UDI-DI
- ++B938PRISM1HEXAMAPSYSHB EUDAMED
- EMDN Code
- C020199 CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Prism-1 Mapping System by Affera, Inc. — Class IIa — 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 | ++B938PRISM1HEXAMAPSYSHB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Affera, Inc.
- EUDAMED SRN
- US-MF-000018093
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 27c9736e-4982-4883-9868-c59adc562576 61 fields · synced Jun 18, 2026