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Impression Tray
EUDAMEDClass I (EU MDR)
Ref /Model IT01,IT0101,IT0102,IT0103,IT0104,IT0105,IT0106,IT0107,IT0108,IT0109,IT0110,IT02,IT0201,IT0202,IT0203,IT0204,IT0205,IT0206,IT0207,IT0208,IT0209,IT0210,IT05,IT07,BT,BT01,BT02,BT03,BT04,BT05,IT08,IT06,TB01,TB01L,TB01M,TB01S,BP01,BP02,BP03,BP04, BP04BRef BT01
Identity
- Trade Name
- Impression Tray EUDAMED
- Device Name
- Impression Tray EUDAMED
- Model / Reference
- IT01,IT0101,IT0102,IT0103,IT0104,IT0105,IT0106,IT0107,IT0108,IT0109,IT0110,IT02,IT0201,IT0202,IT0203,IT0204,IT0205,IT0206,IT0207,IT0208,IT0209,IT0210,IT05,IT07,BT,BT01,BT02,BT03,BT04,BT05,IT08,IT06,TB01,TB01L,TB01M,TB01S,BP01,BP02,BP03,BP04, BP04B EUDAMED/ EUDAMEDBT01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454003060 EUDAMED
- Basic UDI-DI
- 69544540IMTR001WH EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMEDAustria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMEDEUDAMED
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
Impression Tray by Huanghua Promisee Dental Co.Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 69544540IMTR001WH | Class I | Active |
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Manufacturer
- Manufacturer
- Huanghua Promisee Dental Co.Ltd.
- EUDAMED SRN
- CN-MF-000014766
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED b0057ab2-b1d0-45f6-8103-7d139e796fe9 61 fields · synced Oct 8, 2026
- EUDAMED 6a8bb121-0043-42d9-a44b-37c15fe6cea9 61 fields · synced Oct 8, 2026