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Impression Tray M
EUDAMEDClass I (EU MDR)
Ref 1027-8Ref 1100URef 1096LRef 1101URef 1100LRef 1094LRef 1091L
Identity
- Trade Name
- IMPRESSION TRAY M EUDAMEDIMPRESSION TRAY(M) EUDAMEDIMPRESSION TRAY (M) EUDAMED
- Device Name
- IMPRESSION TRAY M EUDAMEDIMPRESISON TRAY (M) EUDAMEDIMPRESSION TRAY(M) EUDAMEDIMPRESSION TRAY (M) EUDAMED
- Model / Reference
- 1027-8 EUDAMED1100U EUDAMED1096L EUDAMED1101U EUDAMED1100L EUDAMED1094L EUDAMED1091L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 1027-8 EUDAMEDD1231100U0 EUDAMEDD1231096L0 EUDAMEDD1231101U0 EUDAMEDD1231100L0 EUDAMEDD1231094L0 EUDAMEDD1231091L0 EUDAMED
- Basic UDI-DI
- ++D12310278C7 EUDAMED++D1231100UD7 EUDAMED++D1231096LED EUDAMED++D1231101UDA EUDAMED++D1231100LCM EUDAMED++D1231094LE7 EUDAMED++D1231091LDW EUDAMED
- EMDN Code
- Q01020199 DENTAL IMPRESSION MATERIALS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Impression Tray M by Dental Expert — 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 | ++D12310278C7 | Class I | Active |
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Manufacturer
- Manufacturer
- Dental Expert
- EUDAMED SRN
- PK-MF-000024595
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (7)
- EUDAMED 613ed595-fe30-4167-8fc9-c707d660e3de 61 fields · synced Jul 21, 2026
- EUDAMED a99ed650-942b-40c1-901c-1fbfa38c565b 61 fields · synced May 18, 2026
- EUDAMED 772d5dde-0466-4d7a-b190-95274e383f8f 61 fields · synced May 18, 2026
- EUDAMED b8add42e-e0ea-4eff-9432-d40db26655df 61 fields · synced May 18, 2026
- EUDAMED de4c756e-f011-437c-a092-5adda2e3c6ee 61 fields · synced May 19, 2026
- EUDAMED 0d13df8e-07f2-496e-a781-207f94da2cdb 61 fields · synced May 19, 2026
- EUDAMED c9788e8c-88fd-4816-9eac-39cab48d8a64 61 fields · synced May 19, 2026