← Back to catalogue
T0.02/15#/120/marked
EUDAMEDClass IIa (EU MDR)
Ref T0.02/15#/120/markedModel Gutta Percha Points
Identity
- Model / Reference
- Gutta Percha Points EUDAMEDT0.02/15#/120/marked EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974922400122 EUDAMED
- Basic UDI-DI
- 697492240GP3U EUDAMED
- EMDN Code
- Q01010201 ROOT CANAL FILLING DENTAL PASTES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental coating, tooth-desensitizing
T0.02/15#/120/marked by Shanghai Xingyu Medical Equipment Co., Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental coating, tooth-desensitizing.
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
- VELLA 5% Sodium Fluoride Varnish Case of 12 Boxes 35 Caramel — Preventech · Class II
- Varnish, Bulk, Oral-B, Bubblegum 1800 — YOUNG DENTAL MANUFACTURING I, LLC · Class II
- VOCO Profluorid Varnish — VOCO GmbH · Class II
- NovaBright — NANOVA BIOMATERIALS INC · Class II
- IRIS — BENCO DENTAL SUPPLY CO. · Class II
- Pulp Canal Sealer — KERR ITALIA SRL · Class IIa
- MICROPRIME — DANVILLE MATERIALS, LLC · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697492240GP3U | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shanghai Xingyu Medical Equipment Co., Ltd
- EUDAMED SRN
- CN-MF-000032268
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 445eac6c-d235-4179-84eb-674460f8b6c4 61 fields · synced Jul 26, 2026