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Reusable breathing circuit (adult)
EUDAMEDClass IIa (EU MDR)
Ref AB0427Ref XMR0041
Identity
- Trade Name
- Reusable breathing circuit (adult) EUDAMED
- Device Name
- Reusable Ventilation Circuit EUDAMED
- Model / Reference
- AB0427 EUDAMEDXMR0041 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980111228 EUDAMED06923980109225 EUDAMED
- Basic UDI-DI
- 69239801NR2SAT6 EUDAMED
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMEDR02010102 BREATHING CIRCUITS, WITH WATER TRAP EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Malta EUDAMEDGermany 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
Reusable breathing circuit (adult) 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 b44f5ea9-d5b4-4237-b44a-356b1a1ad48b 61 fields · synced Jul 16, 2026
- EUDAMED 846886a7-69b7-4a62-9e4e-ea18db3902e5 61 fields · synced May 18, 2026