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Low Frequency Therapeutic Device
EUDAMEDClass IIa (EU MDR)
Ref 867.27Model HD2, HD4P, EM80, SL-880, SL-880H, SL-884, EM49, EM59, EM89, SEM44, FT-810, FT-810-1, FT-810-2, FT-610, FT-610B, EM50, EM55, SEM47, SEM48, SEM53, PP-909, PP-909K, PP-919, EM10, EP-300, SP-610
Identity
- Device Name
- Low Frequency Therapeutic Device EUDAMED
- Model / Reference
- HD2, HD4P, EM80, SL-880, SL-880H, SL-884, EM49, EM59, EM89, SEM44, FT-810, FT-810-1, FT-810-2, FT-610, FT-610B, EM50, EM55, SEM47, SEM48, SEM53, PP-909, PP-909K, PP-919, EM10, EP-300, SP-610 EUDAMED867.27 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04066299867270 EUDAMED
- Basic UDI-DI
- 471988081LFTDM7 EUDAMED
- Direct Marketing DI
- 04066299867270 EUDAMED
- EMDN Code
- Z120622,Z12062801 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Low Frequency Therapeutic Device by Hivox Biotek 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 | 471988081LFTDM7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hivox Biotek Inc.
- EUDAMED SRN
- TW-MF-000052507
- Authorised Representative
- HIVOX BIOTEK B.V. NL-AR-000050977
Sources (1)
- EUDAMED 40e6f65c-9ce2-48de-b3db-86af5570fdea 61 fields · synced Jul 16, 2026