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Gracey Access 16 Pro Thin Xpe Quik Tip
EUDAMEDClass I (EU MDR)
Ref AEGA16TXPQTE
Identity
- Trade Name
- GRACEY ACCESS 16 PRO THIN XPE QUIK TIP EUDAMED
- Device Name
- Periodontal Curette EUDAMED
- Model / Reference
- AEGA16TXPQTE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841013122903 EUDAMED
- Basic UDI-DI
- 0841013141660EMSA737883F3 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
Gracey Access 16 Pro Thin 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 | 0841013141660EMSA737883F3 | 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 0a836e63-1818-4c8e-b148-e529a636750c 61 fields · synced Jul 9, 2026