Identity
- Trade Name
- Anesthesia Circuit, Adult, 1.5m EUDAMEDN/A FDA UDI
- Generic Name
- Anaesthesia breathing circuit, single-use FDA UDI
- Device Name
- Disposable Anesthesia Circuit EUDAMEDAnesthesia Circuit, Adult, 1.5m FDA UDI
- Model / Reference
- AB0437 EUDAMEDFDA UDI
- Description
- Anesthesia Circuit, Adult, 1.5m FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06923980115158 EUDAMEDFDA UDI
- Basic UDI-DI
- 69239801ND2BINZ EUDAMED
- FDA Product Code
- CAI FDA UDI
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMED
- GMDN Term
- Anaesthesia breathing circuit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5240 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Anesthesia Circuit, Adult, 1.5m 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 | 69239801ND2BINZ | 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 9cac6074-a1d2-4dc0-8d0c-a9bd9f9abe70 61 fields · synced Jun 20, 2026
- FDA UDI 344a30c2-4f1d-4d1b-8896-cc985b0b9119 33 fields · synced May 30, 2026