Identity
- Trade Name
- AIOBIO FDA UDI
- Generic Name
- Reflective dental room light FDA UDI
- Model / Reference
- Qscan Plus FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800043200052 FDA UDI
- FDA Product Code
- KYT FDA UDI
- GMDN Term
- Reflective dental room light FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Reflective dental room light
Aiobio by AIOBIO Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Reflective dental room light.
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- Midmark — Midmark Corporation · Class I
- Midmark — Midmark Corporation · Class I
- FARO — F.A.R.O. FABBRICA APPARECCHIATURE RAZIONALI ODONTOIATRICHE SPA · Class I
- Midmark — Midmark Corporation · Class I
- CLESTA LED DENTAL LIGHT — TAKARA BELMONT CORP. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- AIOBIO Co., Ltd.
Sources (1)
- FDA UDI 2267f0ef-7297-49c2-8654-06aeb6ca4fc5 32 fields · synced May 30, 2026