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Hi-Bond Universal 303-2

by Mediclus Co., Ltd

Ref GB2206RC001Model 303-2 Hi-Bond Universal, 303-3 Hi-Bond Universal 2.5

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 24 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880951834RS06NP Basic UDI-DI 08809518342105UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809518342105 UDI-DI Date1 Jun 2026ListedStatusListed 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 24 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  • Withdrawn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
Hi-Bond Universal
Generic Name
Dentine bonding agent/set
Device Name
Dental adhesive material
Model / Ref / Catalog
303-2 Hi-Bond Universal EUDAMED
303-3 Hi-Bond Universal 2.5 EUDAMED
GB2206RC001 EUDAMED
303-2 GUDID
EC2501001 GUDID
Primary DI / UDI-DI
08809518342105
Basic UDI-DI
880951834RS06NP
Direct Marketing DI
08809518342105
510(k) Number
FDA Product Code
KLE
EMDN Code
Q01010104 Dental bonding agents
GMDN Term
Dentine bonding agent/set
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3200
EU market of registration
Romania
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 5 Milliliter

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
303-2 Hi-Bond Universal, 303-3 Hi-Bond Universal 2.5
GB2206RC001
GUDID
303-2
Device ClassEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Other devices from MEDICLUS Co., Ltd.

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Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: 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