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Co-Equal to Standard Blade, Smartrelease
EUDAMEDFDA UDIClass I (EU MDR)
Ref 81061-CE
Identity
- Trade Name
- Co-Equal to Standard Blade, Smartrelease EUDAMEDMicroAire® FDA UDI
- Generic Name
- Hand ligament surgical release instrument FDA UDI
- Device Name
- Handpiece EUDAMEDStandard Co-Equal FDA UDI
- Model / Reference
- 81061-CE EUDAMED81061 FDA UDI
- Description
- Standard Co-Equal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847399005892 EUDAMEDFDA UDI
- Basic UDI-DI
- 08473990SMARTREUSEABLEDC EUDAMED
- FDA Product Code
- EMF FDA UDI
- EMDN Code
- L0915 SPREADERS AND RETRACTORS FOR ORTHOPAEDIC SURGERY, REUSABLE EUDAMED
- GMDN Term
- Hand ligament surgical release instrument FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Italy 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
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
Co-Equal to Standard Blade, Smartrelease by MicroAire Surgical Instruments LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 08473990SMARTREUSEABLEDC | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MicroAire Surgical Instruments LLC
- EUDAMED SRN
- US-MF-000004063
- Authorised Representative
- MediMark Europe Sarl. FR-AR-000000182
Sources (2)
- EUDAMED 96db0728-a173-4dcb-b17a-2dfda0678cf1 61 fields · synced Jul 18, 2026
- FDA UDI b2f58458-33f2-4f52-ac45-29ad7d8efb11 33 fields · synced May 30, 2026