← Back to catalogue
Disposable Impression Trays
EUDAMEDClass I (EU MDR)
Ref DIT1211-1Ref Disposable（Small）Ref DIT1200Ref DIT1213-1Ref DIT1212-1
Identity
- Trade Name
- Disposable Impression Trays EUDAMED
- Device Name
- IMPRESSION TRAYS EUDAMED
- Model / Reference
- DIT1211-1 EUDAMEDDisposable（Small） EUDAMEDDIT1200 EUDAMEDDIT1213-1 EUDAMEDDIT1212-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971241393357 EUDAMED06971241390738 EUDAMED06971241393111 EUDAMED06971241393371 EUDAMED06971241393364 EUDAMED
- Basic UDI-DI
- 697124139DIT0001DU EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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 impression tray, single-use
Disposable Impression Trays by Tangshan Zhengtong Exhibition Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression tray, single-use.
- Miratray Partiell PR 100er — Hager & Werken GmbH & Co. KG · Class I
- COE® — Gc America Inc. · Class I
- Plasdent — PLASDENT CORP. · Class I
- EXCELLENT — PLASDENT CORP. · Class I
- IMPRESSION TRAYS PERFORATED FULL DENTURE UPPER XL U4 — Daddy D Pro · Class I
- Ador-Löffelplatten — dent a pharm Produktionsgesellschaft mbH · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- Disposable Bite Trays — WELLMED DENTAL MEDICAL SUPPLY CO.,LTD · Class I
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 | 697124139DIT0001DU | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Tangshan Zhengtong Exhibition Co., Ltd.
- EUDAMED SRN
- CN-MF-000018452
- Authorised Representative
- Sungo Cert GmbH DE-AR-000010869
Sources (5)
- EUDAMED a02cab35-0b81-493d-a0e4-8a49df640d1a 61 fields · synced Oct 7, 2026
- EUDAMED 33a65ea2-0bef-4119-8c57-aa4ead3d3a2e 61 fields · synced May 17, 2026
- EUDAMED 1ff35279-ec3b-46e8-908b-4c8377744bfe 61 fields · synced May 17, 2026
- EUDAMED 0b793329-d558-490a-80bf-a053ca541d0f 61 fields · synced May 17, 2026
- EUDAMED 727970de-5d32-4f71-a0f5-71149a1b015a 61 fields · synced May 18, 2026