Identity
- Trade Name
- Flow Indicator w/tubing, 160cm EUDAMED
- Device Name
- Disposable Oxygen tubing EUDAMED
- Model / Reference
- AO0029 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06923980106217 EUDAMED
- Basic UDI-DI
- 69239801ND2NBPP EUDAMED
- EMDN Code
- R03010204 OXYGEN ADMINISTRATION TUBINGS 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
Category: Oxygen administration tubing
Flow Indicator w/tubing, 160cm by GaleMed (Xiamen) Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Oxygen administration tubing.
- STRAIGHT CONNECTOR, DISPOSABLE (ID:22mm, OD:15mm) — BESMED HEALTH BUSINESS CORP. · Class I
- PEGASUS — Pegasus Research Corp. · Class I
- 9362 — Oy Fluorplast Ab · Class IIa
- Y-Connector with two 7’ bonded green tubes with ribbed fittings — SALTER LABS · Class IIa
- HUDSON RCI — TELEFLEX INCORPORATED · Class I
- AirLife™ — VYAIRE MEDICAL, INC. · Class I
- Comfort Soft Plus CO2 Sampling Nasal Cannula — WESTMED, INC. · Class II
- Resp-O2 Oxygen Supply Tubing — Dynarex Corp. · Class I
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 | 69239801ND2NBPP | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GaleMed (Xiamen) Co., Ltd.
- EUDAMED SRN
- CN-MF-000020627
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 5d2e75e8-53ee-4779-862c-bedcef0da3d7 61 fields · synced Jul 11, 2026