Identity
- Trade Name
- Silicone J-Circuit, Adult EUDAMEDN/A FDA UDI
- Generic Name
- Ventilator breathing circuit, reusable FDA UDI
- Device Name
- Reusable Ventilation Circuit EUDAMEDSilicone J-Circuit, Adult FDA UDI
- Model / Reference
- AB0090 EUDAMEDFDA UDI
- Description
- Silicone J-Circuit, Adult FDA UDI
Identifiers
- Primary DI / UDI-DI
- 26923980108840 EUDAMEDFDA UDI
- Basic UDI-DI
- 69239801NR2SAT6 EUDAMED
- FDA Product Code
- CAI FDA UDI
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMED
- GMDN Term
- Ventilator breathing circuit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5240 FDA UDI
- Market of Registration
- Italy 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
No
FDA UDI
Silicone J-Circuit, Adult by GaleMed (Xiamen) Co., Ltd. — 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 | 69239801NR2SAT6 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GaleMed (Xiamen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020627
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 111c7eb7-81d4-434b-8e1c-fd1ad0ed7475 61 fields · synced Jun 19, 2026
- FDA UDI 5b312e04-3a3f-42cc-8f84-16a5040ceaec 33 fields · synced May 30, 2026