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Nd:YAG Applicator

by Candela Corporation

Ref Nd:YAG Applicator / 9APP7750-CNDLModel Nd:YAG Applicator

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-00817495023328 Basic UDI-DI 00817495023328UDI-DIDate13 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00817495023328 UDI-DI Date15 Jan 2021ListedStatusListed 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  • Withdrawn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
Nd:YAG Applicator EUDAMED
Applicator Nd:YAG 1064 nm GUDID
Generic Name
Multi-modality skin surface treatment system generator
Model / Reference
Nd:YAG Applicator EUDAMED
Nd:YAG Applicator / 9APP7750-CNDL EUDAMED
9APP7750-CNDL GUDID
Primary DI / UDI-DI
00817495023328
Basic UDI-DI
B-00817495023328
510(k) Number
FDA Product Code
GEX
EMDN Code
Z12011019 Multi–platform laser
GMDN Term
Multi-modality skin surface treatment system generator
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4810
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Nd:YAG Applicator
Nd:YAG Applicator / 9APP7750-CNDL
GUDID
9APP7750-CNDL
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000022750
Authorised representative
AR Experts B.V. NL-AR-000023989

Other devices from Candela Corporation

See all devices from Candela Corporation →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No