Identity
- Trade Name
- HiToP 1touch EUDAMED
- Device Name
- HiToP 1touch EUDAMED
- Model / Reference
- 027-0-0040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260364810035 EUDAMED
- Basic UDI-DI
- B-04260364810035 EUDAMED
- EMDN Code
- Z120601 ELECTROTHERAPY EQUIPMENT (INCLUDED TENS) 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
HiToP 1touch by Gbo Medizintechnik Ag — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04260364810035 | Class IIa | Active |
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Manufacturer
- Manufacturer
- gbo Medizintechnik AG
- EUDAMED SRN
- DE-MF-000018065
Sources (1)
- EUDAMED dbc3f597-1f5f-40b5-9320-6435726eb74a 61 fields · synced Jun 19, 2026