Identity
- Trade Name
- Operio FDA UDI
- Generic Name
- Surgical laminar airflow unit FDA UDI
- Device Name
- Operio M EUDAMEDOperio Mobile is a clean air zone unit, with an integrated detachable instrument tray, to be used in the operating zone, which produces a directed, non-turbulent ultraclean air flow to the surgical site during ophthalmic, orthopedic and neuro surgery and to the sterile instruments used during surgery. FDA UDI
- Model / Reference
- Operio EUDAMED7350101640005 EUDAMEDMobile FDA UDI
- Description
- Operio Mobile is a clean air zone unit, with an integrated detachable instrument tray, to be used in the operating zone, which produces a directed, non-turbulent ultraclean air flow to the surgical site during ophthalmic, orthopedic and neuro surgery and to the sterile instruments used during surgery. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350101640005 EUDAMEDFDA UDI
- Basic UDI-DI
- 735010164OperioY3 EUDAMED
- Direct Marketing DI
- 07350101640005 EUDAMED
- FDA Product Code
- ORC FDA UDI
- EMDN Code
- V0899 MEDICAL SUPPORT EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Surgical laminar airflow unit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.5070 FDA UDI
- Market of Registration
- Austria 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
No
FDA UDI
Category: Surgical laminar airflow unit
Operio by Toul Meditech AB — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical laminar airflow unit.
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- Illuvia — AEROBIOTIX, INC. · Class II
- Illuvia — AEROBIOTIX, INC. · Class II
- Illuvia — AEROBIOTIX, INC. · Class II
- Aerobiotix — AEROBIOTIX, INC. · Class II
- Illuvia — AEROBIOTIX, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Toul Meditech AB
Sources (2)
- FDA UDI 074ac082-2f53-47ed-9f1d-23a928007f7c 33 fields · synced Jun 19, 2026
- EUDAMED e18738d5-e2f3-4fe0-89d3-e4ecd8054af9 61 fields · synced Jun 19, 2026