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Cannulated spherical reamer ⌀10 mm PLUS
EUDAMEDFDA UDIClass I (EU MDR)
Ref 112-A22210Ref 112-A22010
Identity
- Trade Name
- Cannulated spherical reamer ⌀10 mm PLUS EUDAMEDCannulated spherical reamer ⌀ 10 mm EUDAMEDTouch CMC 1 - Cannulated Spherical Reamer Ø10 FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Reamers EUDAMED
- Model / Reference
- 112-A22210 EUDAMED112-A22010 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640181163014 EUDAMED07640181161195 EUDAMEDFDA UDI
- Basic UDI-DI
- 764018116016B9 EUDAMED
- PMA Number
- P240020 FDA UDI
- FDA Product Code
- SFA FDA UDI
- EMDN Code
- L091102 ORTHOPAEDIC PROSTHESES REAMERS AND BURS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass III FDA UDI
- Market of Registration
- France 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
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
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
No
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
Cannulated spherical reamer ⌀10 mm PLUS by Keri Medical SA — Class I — 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 | 764018116016B9 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Keri Medical SA
- EUDAMED SRN
- CH-MF-000021960
- Authorised Representative
- Keri Medical France FR-AR-000009590
Sources (3)
- EUDAMED a879418d-aba2-45bd-b62f-89a79ba6e6da 61 fields · synced Oct 6, 2026
- FDA UDI 07ba2482-86dd-486a-94ea-586f49a33e1d 33 fields · synced May 30, 2026
- EUDAMED c0a17b16-4d9e-489c-83a2-0f65039fc837 61 fields · synced Jul 9, 2026