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TS Simple Mount(SA) GSSMY

by OSSTEM IMPLANT Co., Ltd.

Ref TSSAMR, TSSAMM

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

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
European UnionCE/MDR EUDAMED Number88000406CLASSIBS25V Basic UDI-DI Date10 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809917075758 UDI-DI Date8 Dec 2022ListedStatusListed 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.

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  • Withdrawn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

Trade Name
TS Simple Mount (SA) EUDAMED
TS Simple Mount(SA) GUDID
Generic Name
Dental implant holding endpiece, reusable
Device Name
Instrument System
Model / Reference
TSSAMR EUDAMED
TSSAMM EUDAMED
GSSMY GUDID
Primary DI / UDI-DI
08809917075758 EUDAMED
08809917075741 EUDAMED
08800040617600 EUDAMED
08800000938325 GUDID
Basic UDI-DI
88000406CLASSIBS25V
FDA Product Code
NDP
EMDN Code
Q010599 Dental instruments, single-use - other
GMDN Term
Dental implant holding endpiece, reusable
Device Class
Class I
Regulation Number
872.3980
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
TSSAMR
TSSAMM
GUDID
GSSMY
Primary DI / UDI-DIEUDAMED
08809917075758
08809917075741
08800040617600
GUDID
08800000938325

Related devices

Category: Dental implant holding endpiece, reusable

Other devices from OSSTEM IMPLANT Co., Ltd.

See all devices from OSSTEM IMPLANT Co., Ltd. →

Properties

  • Single Use
  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Implantable: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No