Identity
- Trade Name
- SCALER H7 XPE QUIK TIP EUDAMED
- Device Name
- Manual Dental Scaler, Reusable EUDAMED
- Model / Reference
- AESH7XPQTE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841013123399 EUDAMED
- Basic UDI-DI
- 0841013135320EMND1696817Q EUDAMED
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Scaler H7 Xpe Quik Tip by American Eagle Instruments — 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 | 0841013135320EMND1696817Q | Class I | Active |
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Manufacturer
- Manufacturer
- American Eagle Instruments
- EUDAMED SRN
- US-MF-000018222
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (1)
- EUDAMED be89b4cf-7de9-4688-9e48-b1acf107d8d9 61 fields · synced Jul 11, 2026