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PerFect TCS Straight Round Loop Electrode Sheaths, 2 pcs

by Coltene/Whaledent Inc.

Ref S6014A

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

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-D661S6014A1 Basic UDI-DI D661S6014A1UDI-DIDate7 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD661S6014A1 UDI-DI Date16 Jun 2016ListedStatusListed GUDID: in commercial distribution

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 22 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
PerFect TCS Straight Round Loop Electrode Sheaths, 2 pcs EUDAMED
PerFect TCS GUDID
Generic Name
Electrosurgical system generator
Device Name
PerFect TCS II
Model / Reference
S6014A
Primary DI / UDI-DI
D661S6014A1 EUDAMED
D661S6014A0 GUDID
Basic UDI-DI
B-D661S6014A1
510(k) Number
FDA Product Code
EKZ
EMDN Code
Q010399 Surgical dental devices - other
GMDN Term
Electrosurgical system generator
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
872.4920
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D661S6014A1
GUDID
D661S6014A0
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000015761
Authorised representative
Coltène/Whaledent GmbH + Co. KG DE-AR-000005719

Other devices from Coltene/Whaledent Inc.

See all devices from Coltene/Whaledent Inc. →

Properties

  • Lot / Batch Number

Other properties (23)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No