← Back to catalogue
Sil.Plus
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref AB0038Model (H) Ventilation Circuit
Identity
- Trade Name
- Sil.Plus Circuit, Adult w/2 Water Trap EUDAMEDSil.Plus FDA UDI
- Generic Name
- Anaesthesia breathing circuit, reusable FDA UDI
- Device Name
- Reusable Silicone Circuit EUDAMED
- Model / Reference
- (H) Ventilation Circuit EUDAMEDAB0038 EUDAMEDB121 FDA UDI
Identifiers
- Catalog Number
- adult-Circuit w/water trap FDA UDI
- Primary DI / UDI-DI
- 24710810117101 EUDAMEDFDA UDI
- Basic UDI-DI
- 471081008RNHB9C EUDAMED
- Direct Marketing DI
- 24710810117101 EUDAMED
- FDA Product Code
- CAI FDA UDI
- EMDN Code
- R02010102 BREATHING CIRCUITS, WITH WATER TRAP EUDAMED
- GMDN Term
- Anaesthesia breathing circuit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5240 FDA UDI
- Market of Registration
- Netherlands 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Anaesthesia breathing circuit, reusable
Sil.Plus by Galemed Corp. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia breathing circuit, reusable.
- Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit — Global Life Sciences Solutions USA LLC · Class II
- MATRX SCAV, W/SM HOOD(WO/SHUTOF — Parker Hannifin Corp. · Class I
- AirTechniques — Baldus Sedation GmbH & Co. KG · Class I
- PORTER/BRN ADULT RG ASSY ONLY — Parker Hannifin Corp. · Class I
- Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit — Global Life Sciences Solutions USA LLC · Class II
- 30MM UNIFLOW COAXIAL BREATHING SYSTEM WITH LUER ELBOW, AND LIMB, 2.4M — Intersurgical Incorporated · Class I
- Ultipor™ Anesthesia Breathing Circuit System - Pediatric Machine Kit — Global Life Sciences Solutions USA LLC · Class II
- Trulink — SPACELABS HEALTHCARE (WASHINGTON), 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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Galemed Corp.
Sources (2)
- FDA UDI 52f5395e-546a-4dc9-9a18-34bf3b049caa 33 fields · synced Jul 17, 2026
- EUDAMED 62260d74-2b50-4686-8cf3-7f6b5869b8c7 61 fields · synced Jul 17, 2026