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(10)Flex Trach Adaptor 15cm, 22M/15F-22F
EUDAMEDClass IIa (EU MDR)
Ref XRE0009Model (I) Anesthesia Circuit
Identity
- Trade Name
- (10)Flex Trach Adaptor 15cm, 22M/15F-22F EUDAMED
- Device Name
- Catheter Mount EUDAMED
- Model / Reference
- (I) Anesthesia Circuit EUDAMEDXRE0009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810094095 EUDAMED
- Basic UDI-DI
- 471081008NNI47R EUDAMED
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP 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
(10)Flex Trach Adaptor 15cm, 22M/15F-22F 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 | 471081008NNI47R | 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 f686a719-27eb-4cbe-9f68-083d3379892e 61 fields · synced Jul 9, 2026