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(10)Flex Trach Adapt 15cm, 22M/15F-15M
EUDAMEDClass IIa (EU MDR)
Ref XRE0008Model (I) Anesthesia Circuit
Identity
- Trade Name
- (10)Flex Trach Adapt 15cm,22M/15F-15M EUDAMED
- Device Name
- Catheter Mount EUDAMED
- Model / Reference
- (I) Anesthesia Circuit EUDAMEDXRE0008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810094101 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 Adapt 15cm, 22M/15F-15M 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 27eb2e72-3ebc-4ba1-8c74-c165d8d33e6e 61 fields · synced Jun 18, 2026