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Hytrel Ckt, Child, 120cm w/Water Trap
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AB0027Model (H) Ventilation Circuit
Identity
- Trade Name
- Hytrel Ckt, Child, 120cm w/Water Trap EUDAMEDN/A FDA UDI
- Generic Name
- Anaesthesia breathing circuit, reusable FDA UDI
- Device Name
- Reusable Hytrel Circuit EUDAMED
- Model / Reference
- (H) Ventilation Circuit EUDAMEDAB0027 EUDAMED6806 FDA UDI
Identifiers
- Catalog Number
- HBCW Child Breathing Circuit w/one water trap FDA UDI
- Primary DI / UDI-DI
- 44710810110106 EUDAMEDFDA UDI
- Basic UDI-DI
- 471081008RNH88S EUDAMED
- Direct Marketing DI
- 44710810110106 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
Hytrel Ckt, Child, 120cm w/Water Trap 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 | 471081008RNH88S | 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 (2)
- EUDAMED 70f679fe-7cc8-4890-9d89-67fe5a2ffdae 61 fields · synced Aug 3, 2026
- FDA UDI b2220444-1377-429a-8590-61d77220ca91 34 fields · synced May 30, 2026