Identity
- Trade Name
- SCALER J3-U5 XPE (3/8) GREEN EUDAMED
- Device Name
- Manual Dental Scaler, Reusable EUDAMED
- Model / Reference
- AESJ3-U5XPXE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841013123412 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 J3-U5 Xpe (3/8) Green 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 cb2bfb0f-cdcc-4ffb-a0ae-e54e4282b2a7 61 fields · synced Jun 18, 2026