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Light Post Adapter, Wolf, SmartRelease
EUDAMEDFDA UDIClass I (EU MDR)
Ref 81152-CE
Identity
- Trade Name
- Light Post Adapter, Wolf, SmartRelease EUDAMEDMicroAire® FDA UDI
- Generic Name
- Light source adaptor FDA UDI
- Device Name
- SmartRelease Accessories EUDAMEDWolf Light Post Adapter FDA UDI
- Model / Reference
- 81152-CE EUDAMED81152 FDA UDI
- Description
- Wolf Light Post Adapter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847399005915 EUDAMEDFDA UDI
- Basic UDI-DI
- 08473990SMARTACCSW9 EUDAMED
- FDA Product Code
- EMF FDA UDI
- EMDN Code
- Z12020980 NEUROENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Light source adaptor 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
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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Light Post Adapter, Wolf, 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 | 08473990SMARTACCSW9 | 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 92babc35-d495-4174-8625-ceaa4b071537 61 fields · synced Jul 27, 2026
- FDA UDI b3d61476-7be1-4ea3-a3c6-dd3c9dd2803b 33 fields · synced May 29, 2026