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Columbia 2l-2r Xp (3/8) Orange
EUDAMEDFDA UDIClass I (EU MDR)
Ref AECC2L-2RXPXE
Identity
- Trade Name
- COLUMBIA 2L-2R XP (3/8) ORANGE EUDAMEDAmerican Eagle Instruments FDA UDI
- Generic Name
- Periodontal curette FDA UDI
- Device Name
- Periodontal Curette EUDAMEDCOLUMBIA 2L-2R XP (3/8) ORANGE FDA UDI
- Model / Reference
- AECC2L-2RXPXE EUDAMEDFDA UDI
- Description
- COLUMBIA 2L-2R XP (3/8) ORANGE FDA UDI
Identifiers
- Catalog Number
- AECC2L-2RXPXE FDA UDI
- Primary DI / UDI-DI
- 00841013120268 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841013141660EMSA737883F3 EUDAMED
- FDA Product Code
- EMS FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Periodontal curette 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
Dry Heat Sterilization FDA UDI
Columbia 2l-2r 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 | 0841013141660EMSA737883F3 | 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 67e176d9-ac68-4f81-b285-79e92b2fa1cc 61 fields · synced Jun 18, 2026
- FDA UDI e3227a5a-61d9-4ff1-898d-a107c04ddb0a 35 fields · synced May 30, 2026