Identity
- Trade Name
- Avalign FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, flexible FDA UDI
- Device Name
- Flexible Reamer EUDAMEDMonobloc Flexible IM Reamer, 6 Flute, for Ø2.3mm GW, 6.0mm FDA UDI
- Model / Reference
- 9015.03.060 EUDAMEDFDA UDI
- Description
- Monobloc Flexible IM Reamer, 6 Flute, for Ø2.3mm GW, 6.0mm FDA UDI
Identifiers
- Catalog Number
- 9015.03.060 FDA UDI
- Primary DI / UDI-DI
- 00190776148508 EUDAMEDFDA UDI
- Basic UDI-DI
- 0190776REAMERRF EUDAMED
- Direct Marketing DI
- 00190776148508 EUDAMED
- FDA Product Code
- HTO FDA UDI
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
- GMDN Term
- Medullary canal orthopaedic reamer, flexible FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Bulgaria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Acetabular orthopaedic reamer
Flexible Reamer by AVALIGN TECHNOLOGIES, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0190776REAMERRF | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Avalign Technologies Inc.
- EUDAMED SRN
- US-MF-000008511
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 33735ec7-48b4-49d6-9b8e-e25cea21f189 61 fields · synced Jun 19, 2026
- FDA UDI a778197e-b472-4141-a296-008ceb6ff689 35 fields · synced May 30, 2026