Identity
- Device Name
- Catheter Extension Cable EUDAMED
- Model / Reference
- AFR-00006 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B938AFR000060 EUDAMED
- Basic UDI-DI
- ++B938SPH9EXTCABLEK7 EUDAMED
- EMDN Code
- C020180 CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Catheter Extension Cable by Affera, 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 | ++B938SPH9EXTCABLEK7 | Class I | Active |
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Manufacturer
- Manufacturer
- Affera, Inc.
- EUDAMED SRN
- US-MF-000018093
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED e42536d8-5035-4654-8699-1d33610cecb7 61 fields · synced Jun 18, 2026