Identity
- Trade Name
- Aladin2 Desflurane Saf-fil EUDAMEDAladin2 FDA UDI
- Generic Name
- Desflurane anaesthesia vaporizer FDA UDI
- Device Name
- Aladin2 Desflurane Saf-fil EUDAMED
- Model / Reference
- 1100-9026-000 EUDAMEDDES SAF-FIL B FDA UDI
Identifiers
- Catalog Number
- 1100-9026-000 FDA UDI
- Primary DI / UDI-DI
- 00840682100281 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00840682100281 EUDAMED
- 510(k) Number
- K132530 FDA UDI
- FDA Product Code
- BSZ FDA UDI
- EMDN Code
- Z1203010180 ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Desflurane anaesthesia vaporizer FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5160 FDA UDI
- Market of Registration
- Finland 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
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
No
FDA UDI
MR Unsafe FDA UDI
Aladin2 Desflurane Saf-fil by Datex-Ohmeda Inc. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00840682100281 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Datex-Ohmeda Inc.
- EUDAMED SRN
- US-MF-000014656
- Authorised Representative
- GE Healthcare Finland Oy FI-AR-000017101
Sources (2)
- EUDAMED 3ca2837a-b76e-4783-b953-806a45e4de8c 61 fields · synced Jul 16, 2026
- FDA UDI b3ec9ce8-4fb6-4629-917f-42382311141c 36 fields · synced May 30, 2026