Identity
- Trade Name
- Miratray Implant OK S3 EUDAMED
- Device Name
- Abformlöffel, für Implantate EUDAMED
- Model / Reference
- 000300 EUDAMED101153 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04099637003085 EUDAMED
- Basic UDI-DI
- 40996370003003D EUDAMED
- Unit of Use DI
- 04099637003078 EUDAMED
- EMDN Code
- Q010503 IMPRESSION MATERIAL TRAYS, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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: Dental impression tray, single-use
Miratray Implant OK S3 by Hager & Werken GmbH & Co. KG — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental impression tray, single-use.
- COE® — Gc America Inc. · Class I
- Plasdent — PLASDENT CORP. · Class I
- EXCELLENT — PLASDENT CORP. · Class I
- IMPRESSION TRAYS PERFORATED FULL DENTURE UPPER XL U4 — Daddy D Pro · Class I
- Ador-Löffelplatten — dent a pharm Produktionsgesellschaft mbH · Class I
- BENCO — BENCO DENTAL SUPPLY CO. · Class I
- Disposable Bite Trays — WELLMED DENTAL MEDICAL SUPPLY CO.,LTD · Class I
- Zap Dual Arch Flouride Gel Trays — CROSSTEX INTERNATIONAL, INC. · Class I
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 | 40996370003003D | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hager & Werken GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000004938
Sources (1)
- EUDAMED e415f491-83e9-4347-a7e2-02a934881df2 61 fields · synced Oct 6, 2026