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Secret RF Set Package MTR-C1

by CLASSYS Inc.

Ref Secret RF

Secret RF Set Package MTR-C1 is a device classified as Class IIb in the EU and Class II in the US made by CLASSYS Inc., registered in EUDAMED on 11 Jun 2026 (Basic UDI-DI B-08800016903287), cleared under FDA 510(k) K170325 on 13 Jun 2017 and listed in FDA GUDID since 25 Oct 2024 (UDI-DI 08800016903287), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K170325

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08800016903287 Basic UDI-DI 08800016903287UDI-DIDate11 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800016903287 UDI-DI Date25 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK170325 Date13 Jun 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800016903287 registered 11 Jun 2026 Active
  • FDA 510(k) K170325 decided 13 Jun 2017 Active
  • FDA GUDID UDI-DI 08800016903287 listed 25 Oct 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K170325
  2. Listed FDA GUDID 08800016903287
  3. Registered EUDAMED B-08800016903287

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Secret RF EUDAMED
Secret RF Set Package GUDID
Generic name
Intradermal radio-frequency ablation system
Device name
High frequency surgical system with sterile micro needle electrodes
Model / reference
Secret RF EUDAMED
MTR-C1 GUDID
Primary DI / UDI-DI
08800016903287
Basic UDI-DI
B-08800016903287
510(k) Number
FDA product code
GEI, OUH
EMDN code
Z12010905 Radiosurgical units
GMDN term
Intradermal radio-frequency ablation system
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Secret RF
GUDID
MTR-C1
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Intradermal radio-frequency ablation system

Cleared under the same submission (K170325)

and 2 more cleared under K170325

Similar devices in this category

Other devices filed under RADIOSURGICAL UNITS.

Other devices from CLASSYS Inc.

See all devices from CLASSYS Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)