Identity
- Trade Name
- (10)Flex Trach Adapt 15cm,22M/15F-15M EUDAMED
- Device Name
- Disposable Tubing and hose EUDAMED
- Model / Reference
- XRE0008 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980106415 EUDAMED
- Basic UDI-DI
- 69239801ND2QAPW EUDAMED
- EMDN Code
- R020202 MOBILE CATHETER MOUNTS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 (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 | 69239801ND2QAPW | 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 (1)
- EUDAMED 8535e928-87eb-41a4-bc2f-50f63f3ecb3d 61 fields · synced Jul 8, 2026