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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 BT
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/ EUDAMEDBT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06954454001011 EUDAMED
- Basic UDI-DI
- 69544540IMTR001WH EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Croatia 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
Category: Dental impression tray, single-use
Impression Tray by Huanghua Promisee Dental Co.Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Dental impression tray, single-use.
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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 | 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 637cfeff-7f22-4869-bd87-8a6446373ad6 61 fields · synced Oct 8, 2026
- EUDAMED 7ff2c929-c9be-4818-bbd7-67c7c7d9af13 61 fields · synced Oct 8, 2026