Module Acutrode
by Sedatelec
Ref 113548
Module Acutrode (113548) is a medical device (EU MDR Class I; EMDN category acupuncture stimulators) made by Sedatelec, registered in EUDAMED on 4 Feb 2026 (Basic UDI-DI 3760262491202Y7), active as of 24 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number3760262491202Y7 03760262493763 | Date4 Feb 2026 | StatusActive |
Official records
- EUDAMED public site 3760262491202Y7
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- 113548
- Primary DI / UDI-DI
- 03760262493763
- Basic UDI-DI
- 3760262491202Y7
- EMDN code
- Z120623 Acupuncture stimulators
- Device class
- Class I
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000020946
Similar devices in this category
Other devices filed under ACUPUNCTURE STIMULATORS.
- MAI DEVICE MA0222 by NEUROSTIMULATION MEDTECH PRIVATE LIMITED
- Pointer Excel II ED3988 by TENS PLUS INDUSTRIAL COMPANY
- Needle Stimulator CMNS6-1 PLUS by Wuxi Jiajian Medical Instrument Co., Ltd.
- Needle Stimulator CMNS6-3 by Wuxi Jiajian Medical Instrument Co., Ltd.
- AXUS ES-5 ED3930 by TENS PLUS INDUSTRIAL COMPANY