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Model Resin
EUDAMEDClass I (EU MDR)
Ref YH-M-HT-001Model HD，HR，HL，H0，HY，HT，H250，H350，H60，HL250，HL350，HL60
Identity
- Trade Name
- Model Resin EUDAMED
- Device Name
- Model Resin EUDAMED
- Model / Reference
- HD，HR，HL，H0，HY，HT，H250，H350，H60，HL250，HL350，HL60 EUDAMEDYH-M-HT-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978486170118 EUDAMED
- Basic UDI-DI
- 697848617ModelResinNB EUDAMED
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER 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: Silicone dental impression material
Model Resin by Sichuan Yonghe Medical Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697848617ModelResinNB | Class I | Active |
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Manufacturer
- Manufacturer
- Sichuan Yonghe Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000051226
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (1)
- EUDAMED 7d5002b9-1ad4-47f6-ab47-8a959a8070bb 61 fields · synced Jun 17, 2026