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actiTENS mini

by Sublimed

Ref SBM7AA100

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03770018808260 UDI-DI Date27 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number3770018808SBMTENSAPPNU Basic UDI-DI 03770018808260UDI-DIDate23 Jun 2023RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Analgesic transcutaneous electrical nerve stimulation system
Device Name
actiTENS / actiTENS mini/ VitaliTENS / VitaliTENS mini
Model / Ref / Catalog
SBM7AA100, actiTENS Mini
Primary DI / UDI-DI
03770018808260
Basic UDI-DI
3770018808SBMTENSAPPNU
Direct Marketing DI
03770018808260
510(k) Number
FDA Product Code
GZJ, NYN, IPF, NGX, NUH
EMDN Code
Z120601 Electrotherapy equipment (included tens)
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.5890, 890.5850
EU market of registration
France
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
SBM7AA100
GUDID
actiTENS Mini
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
FR-MF-000007546

Other devices from Sublimed

See all devices from Sublimed →

Properties

  • Prescription Use
  • Over-the-Counter
  • Serial Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No