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Scaler Neb 128 (de) Xp (3/8) Orange
EUDAMEDFDA UDIClass I (EU MDR)
Ref AESN128DEXPXE
Identity
- Trade Name
- SCALER NEB 128 (DE) XP (3/8) ORANGE EUDAMEDAmerican Eagle Instruments FDA UDI
- Generic Name
- Manual dental scaler, reusable FDA UDI
- Device Name
- Manual Dental Scaler, Reusable EUDAMEDSCALER NEB 128 (DE) XP (3/8) ORANGE FDA UDI
- Model / Reference
- AESN128DEXPXE EUDAMEDFDA UDI
- Description
- SCALER NEB 128 (DE) XP (3/8) ORANGE FDA UDI
Identifiers
- Catalog Number
- AESN128DEXPXE FDA UDI
- Primary DI / UDI-DI
- 00841013120381 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841013135320EMND1696817Q EUDAMED
- FDA Product Code
- EMN FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Manual dental scaler, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Scaler Neb 128 (de) Xp (3/8) Orange by American Eagle Instruments — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0841013135320EMND1696817Q | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- American Eagle Instruments
- EUDAMED SRN
- US-MF-000018222
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (2)
- EUDAMED 2cd0c56b-1795-43a6-9f2e-dc5738c58991 61 fields · synced Jul 14, 2026
- FDA UDI ab372ecd-b19b-4825-a61f-c17b8e5d8d9a 35 fields · synced May 29, 2026