Identity
- Trade Name
- pfm Zahnschutz, EUDAMED
- Device Name
- iMED Tooth Protector EUDAMED
- Model / Reference
- 640012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05745000816002 EUDAMED
- Basic UDI-DI
- 5745000816TPTPE7N EUDAMED
- EMDN Code
- T0306 PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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: Radiation/mechanical corneal shield, reusable
pfm Zahnschutz, by iMED ApS — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radiation/mechanical corneal shield, reusable.
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- SOFT CARE — BOURNAS MEDICALS · Class I
- STOCKINETTE ROULEE 1/1 COTON ECRU 15x150 M6 — MAILL'TUB · Class I
- CONCHIGLIA OCULARE — Surgika srl · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- Sani-Tab Chain-Free Econoback Towels — CROSSTEX INTERNATIONAL, INC. · Class I
- Champ Fenêtré Adhésif — JiangSu MedPlus Non-Woven Manufacturer Co., Ltd · Class I
- Simplex-Plus Maxi kék nyálkendő — Dentalia Dentálgyártmány Kft. · 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 | 5745000816TPTPE7N | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- iMED ApS
- EUDAMED SRN
- DK-MF-000032070
Sources (1)
- EUDAMED aae607be-47b6-4f8a-b5eb-92a05bb08c93 61 fields · synced Jul 13, 2026