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Model Resin
EUDAMEDClass I (EU MDR)
Ref YH-M-H60-001Model HD，HR，HL，H0，HY，HT，H250，H350，H60，HL250，HL350，HL60Ref YH-M-HY-001Ref YH-M-H350-001Ref YH-M-H250-001Ref YH-M-HD-001Ref YH-M-H0-001Ref YH-M-HL60-001Ref YH-M-HL350-001
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-H60-001 EUDAMEDYH-M-HY-001 EUDAMEDYH-M-H350-001 EUDAMEDYH-M-H250-001 EUDAMEDYH-M-HD-001 EUDAMEDYH-M-H0-001 EUDAMEDYH-M-HL60-001 EUDAMEDYH-M-HL350-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978486170149 EUDAMED06978486170101 EUDAMED06978486170132 EUDAMED06978486170125 EUDAMED06978486170064 EUDAMED06978486170095 EUDAMED06978486170170 EUDAMED06978486170163 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 (8)
- EUDAMED b6147cb0-41d2-4723-b850-55cc26b30447 61 fields · synced Jul 31, 2026
- EUDAMED f2d59648-7bec-4244-9c24-2d98ef2f52a5 61 fields · synced May 17, 2026
- EUDAMED dfee08e9-ab5d-47c2-b5c0-675d803ea7d6 61 fields · synced May 17, 2026
- EUDAMED 8798b48e-4329-43b4-b620-098a2e7b0392 61 fields · synced May 18, 2026
- EUDAMED 24d61d16-b45f-4a8f-9efd-0f88e451b66d 61 fields · synced May 18, 2026
- EUDAMED 256c751a-7cd9-47db-bbcf-b4bf43962a58 61 fields · synced May 18, 2026
- EUDAMED 3e1d8ad6-b470-42a4-b978-83cc2b178d36 61 fields · synced May 18, 2026
- EUDAMED 2ac89fd8-ec95-440d-88a8-1ac938293f41 61 fields · synced May 19, 2026