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Silicone Single Limb Circuit, Adult
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AB0337Model (H) Ventilation CircuitRef AB0028
Identity
- Trade Name
- Silicone Single Limb Circuit, Adult EUDAMEDN/A FDA UDI
- Generic Name
- Anaesthesia breathing circuit, reusable FDA UDI
- Device Name
- Silicone Circuit EUDAMEDReusable Silicone Circuit EUDAMED
- Model / Reference
- (H) Ventilation Circuit EUDAMEDAB0337 EUDAMEDAB0028 EUDAMED7105 FDA UDI
Identifiers
- Catalog Number
- Durable Single Limb Circuit FDA UDI
- Primary DI / UDI-DI
- 04710810105487 EUDAMED24710810110997 EUDAMEDFDA UDI
- Basic UDI-DI
- 471081008NNHB8G EUDAMED471081008RNHB9C EUDAMED
- Direct Marketing DI
- 24710810110997 EUDAMED
- FDA Product Code
- CAI FDA UDI
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMEDR02010102 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
Silicone Single Limb Circuit, Adult by GaleMed Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 471081008NNHB8G | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED 3c3b84c0-3ec1-4de0-99ca-080d35d1da7f 61 fields · synced Jul 30, 2026
- FDA UDI 6960e587-36df-45e0-bb97-e1477a3ab288 34 fields · synced May 30, 2026
- EUDAMED d511352e-0fe4-4bcc-b89e-d3b5fdd9dd2a 61 fields · synced Jul 30, 2026