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Theta Circuit, 180cm
EUDAMEDClass IIa (EU MDR)
Ref AB0057Model (I) Anesthesia Circuit
Identity
- Trade Name
- Theta Circuit, 180cm EUDAMED
- Device Name
- Coaxial Circuit EUDAMED
- Model / Reference
- (I) Anesthesia Circuit EUDAMEDAB0057 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810117640 EUDAMED
- Basic UDI-DI
- 471081008NNI27M EUDAMED
- EMDN Code
- R020102 COAXIAL BREATHING CIRCUITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Theta Circuit, 180cm by GaleMed Corporation — 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 | 471081008NNI27M | Class IIa | Active |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED cedc182a-b2b6-4e74-a1e5-ae4f514e1134 61 fields · synced Jun 19, 2026