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Sil.Plus Circuit, Child w/2 Water Trap
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AB0037Model (H) Ventilation Circuit
Identity
- Trade Name
- Sil.Plus Circuit, Child w/2 Water Trap EUDAMEDSil.Plus FDA UDI
- Generic Name
- Anaesthesia breathing circuit, reusable FDA UDI
- Device Name
- Reusable Ventilation Circuit EUDAMEDReusable Silicone Circuit EUDAMED
- Model / Reference
- AB0037 EUDAMED(H) Ventilation Circuit EUDAMEDB111 FDA UDI
Identifiers
- Catalog Number
- pedi-Circuit w/water trap FDA UDI
- Primary DI / UDI-DI
- 26923980109205 EUDAMED24710810119198 EUDAMEDFDA UDI
- Basic UDI-DI
- 69239801NR2SAT6 EUDAMED471081008RNHB9C EUDAMED
- Direct Marketing DI
- 24710810119198 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
- Germany EUDAMEDNetherlands 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
Sil.Plus Circuit, Child w/2 Water Trap 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 (3)
- EUDAMED 7a7c3997-46d4-4669-a609-8913edf3fbc1 61 fields · synced Jul 22, 2026
- FDA UDI 042a3db0-7679-4db9-b41a-521710b14b98 33 fields · synced May 29, 2026
- EUDAMED a30c1186-195a-43a9-9e60-06da82e5c6c2 61 fields · synced Jul 22, 2026