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AutoClavable Endoscope, SmartRelease
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 81025-CE
Identity
- Trade Name
- AutoClavable Endoscope, SmartRelease EUDAMEDMicroAire® FDA UDI
- Generic Name
- Rigid optical arthroscope, reusable FDA UDI
- Device Name
- Endoscope EUDAMEDAUTOCLAVABLE ENDOSCOPE, SMARTRELEASE FDA UDI
- Model / Reference
- 81025-CE EUDAMED81025 FDA UDI
- Description
- AUTOCLAVABLE ENDOSCOPE, SMARTRELEASE FDA UDI
Identifiers
- Catalog Number
- 81025-CE FDA UDI
- Primary DI / UDI-DI
- 00847399005823 EUDAMEDFDA UDI
- Basic UDI-DI
- 08473990SMARTENDOYP EUDAMED
- Direct Marketing DI
- 00847399005823 EUDAMED
- FDA Product Code
- HRX FDA UDI
- EMDN Code
- Z12020902 NEUROSCOPES EUDAMED
- GMDN Term
- Rigid optical arthroscope, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.1100 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
AutoClavable Endoscope, SmartRelease by MicroAire Surgical Instruments LLC — Class IIa — 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 | 08473990SMARTENDOYP | 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 d20e6003-46ab-432a-b662-b3265480392a 61 fields · synced Jun 18, 2026
- FDA UDI 193c543a-8e83-42ce-97f5-d6d4867defe5 34 fields · synced May 30, 2026