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Silicone Circuit, Infant 120cm, w/2WT
EUDAMEDClass IIa (EU MDR)
Ref AB0089Model (H) Ventilation Circuit
Identity
- Trade Name
- Silicone Circuit, Infant 120cm, w/2WT EUDAMED
- Device Name
- Reusable Ventilation Circuit EUDAMEDReusable Silicone Circuit EUDAMED
- Model / Reference
- AB0089 EUDAMED(H) Ventilation Circuit EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26923980109113 EUDAMED24710810103395 EUDAMED
- Basic UDI-DI
- 69239801NR2SAT6 EUDAMED471081008RNHB9C EUDAMED
- Direct Marketing DI
- 24710810103395 EUDAMED
- EMDN Code
- R02010102 BREATHING CIRCUITS, WITH WATER TRAP EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDNetherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Silicone Circuit, Infant 120cm, w/2WT by GaleMed (Xiamen) Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69239801NR2SAT6 | Class IIa | Active |
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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 71c7e052-4f01-44c6-9ec8-b55ea685b7d3 61 fields · synced Jul 21, 2026
- EUDAMED 66c86063-37e8-4779-8168-4ffdf11e04b4 61 fields · synced Jul 16, 2026