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Low Speed/ Universal Handpiece Sleeves

by Premium Plus (Dongguan) Limited

Ref 104L, 104S

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 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

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
United StatesGUDID listing GUDID Number+D125104L2 UDI-DI Date22 May 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number++D125BRSLEEVE2W Basic UDI-DI Date31 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Low Speed/ Universal Handpiece Sleeves EUDAMED
Premium Plus GUDID
Generic Name
Digital imaging cassette
Device Name
Barrier Sleeves
Model / Reference
104L, 104S
Primary DI / UDI-DI
+D125104L2 EUDAMED
+D125104S2 EUDAMED
D125104S2 GUDID
D125104L2 GUDID
Basic UDI-DI
++D125BRSLEEVE2W
Unit of Use DI
2
510(k) Number
FDA Product Code
PEM
EMDN Code
T0399 Protection devices (excluding personal protective equipment PPE) - other
GMDN Term
Digital imaging cassette
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
878.4370
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+D125104L2
+D125104S2
GUDID
D125104S2
D125104L2
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000038259
Authorised representative
Premium Plus Poland sp. z o.o. PL-AR-000030110

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

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