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SmartRelease Endoscopic Soft Tisssue Release, Standard Blade Assembly
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 81010-6-CE
Identity
- Trade Name
- SmartRelease Endoscopic Soft Tisssue Release, Standard Blade Assembly EUDAMEDMicroAire® FDA UDI
- Generic Name
- Hand ligament surgical release instrument FDA UDI
- Device Name
- Blade Assembly EUDAMEDStandard (U) Blade Assembly 6pk FDA UDI
- Model / Reference
- 81010-6-CE EUDAMED81010-6 FDA UDI
- Description
- Standard (U) Blade Assembly 6pk FDA UDI
Identifiers
- Catalog Number
- 81010-6-CE FDA UDI
- Primary DI / UDI-DI
- 00847399005762 EUDAMEDFDA UDI
- Basic UDI-DI
- 08473990SMARTRELEASENA EUDAMED
- Unit of Use DI
- 00847399005755 EUDAMED
- FDA Product Code
- EMF FDA UDI
- EMDN Code
- V0199 CUTTING DEVICES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Hand ligament surgical release instrument FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cranial bur, single-use
SmartRelease Endoscopic Soft Tisssue Release, Standard Blade Assembly by MicroAire Surgical Instruments LLC — Class IIa — MDR, FDA UDI — listed in EUDAMED…
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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 | 08473990SMARTRELEASENA | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 85e029a5-298e-4994-8b3f-3e33e8d508a9 61 fields · synced Jul 22, 2026
- FDA UDI 66311a0a-2655-46a5-ba0d-2ed19eb6c559 34 fields · synced May 30, 2026