Identity
- Trade Name
- C.S. HANDLE ROUND (3/8) EUDAMEDAmerican Eagle Instruments FDA UDI
- Generic Name
- Manual non-rotary dental instrument handle FDA UDI
- Device Name
- Manual Non-rotary Dental Instrument Handle EUDAMED
- Model / Reference
- AEMHRX EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841013108730 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841013164304EJBA73788633 EUDAMED
- FDA Product Code
- EJB FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Manual non-rotary dental instrument handle FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Ireland 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
C.s. Handle Round (3/8) 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 | 0841013164304EJBA73788633 | 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 b8e3680e-acd2-4fad-930d-9efa2d18c898 61 fields · synced Aug 2, 2026
- FDA UDI 2bd4cbff-2b20-4ef4-9bc5-b34fc7eb7f50 32 fields · synced May 30, 2026