Identity
- Trade Name
- ECG Amplifier Unit EUDAMED
- Device Name
- Sphygmomanometer and Sphygmograph EUDAMED
- Model / Reference
- EE-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04538612912429 EUDAMED
- Basic UDI-DI
- 4538612011009K EUDAMED
- EMDN Code
- C9006,Z12050301 EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ECG Amplifier Unit by Fukuda Denshi Co., Ltd. — 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 | 4538612011009K | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fukuda Denshi Co., Ltd.
- EUDAMED SRN
- JP-MF-000008253
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED a5e8692d-499c-4355-9ccd-cc52e57cb694 61 fields · synced Jun 19, 2026