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Reinforced Endotracheal Tube
EUDAMEDClass IIa (EU MDR)
Ref 91050004Model Cuffled,ID:4.5#Ref 91050013Model Cuffled,ID:9.0#Ref 91050010Model Cuffled,ID:7.5#Ref 91050002Model Cuffled,ID:3.5#Ref 91050015Model Cuffled,ID:10.0#Ref 91050014Model Cuffled,ID:9.5#
Identity
- Trade Name
- Reinforced Endotracheal Tube EUDAMED
- Device Name
- Reinforced Endotracheal Tube EUDAMED
- Model / Reference
- Cuffled,ID:4.5# EUDAMED91050004 EUDAMEDCuffled,ID:9.0# EUDAMED91050013 EUDAMEDCuffled,ID:7.5# EUDAMED91050010 EUDAMEDCuffled,ID:3.5# EUDAMED91050002 EUDAMEDCuffled,ID:10.0# EUDAMED91050015 EUDAMEDCuffled,ID:9.5# EUDAMED91050014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972745360432 EUDAMED06972745360524 EUDAMED06972745360494 EUDAMED06972745360418 EUDAMED06972745360548 EUDAMED06972745360531 EUDAMED
- Basic UDI-DI
- B-06972745360432 EUDAMEDB-06972745360524 EUDAMEDB-06972745360494 EUDAMEDB-06972745360418 EUDAMEDB-06972745360548 EUDAMEDB-06972745360531 EUDAMED
- EMDN Code
- R01030202 ENDOTRACHEAL TUBES, CUFFED, REINFORCED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDEUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Reinforced endotracheal tube, single-use
Reinforced Endotracheal Tube by Guangzhou Orcl Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Reinforced endotracheal tube, single-use.
- Rurka intubacyjna bez mankietu — SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa · Class IIa
- Disposable Tracheal tubes — Shaoxing Carere Medical Appliance Co., Ltd. · Class IIa
- Disposable Tracheal Tubes With Cuff — NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD · Class IIa
- cuff — Contec Medical Systems Co., Ltd. · Class I
- RUSCH — TELEFLEX INCORPORATED · Class II
- Welllead Reinforced Tracheal Tube — Well Lead Medical Co., Ltd · Class IIa
- Disposable Endotracheal Tubes — Rmist(Tianjin) Medical Device Co., Ltd. · Class IIa
- Endotracheal Tube — HANGZHOU FORMED MEDICAL DEVICES CO., LTD. · Class IIa
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06972745360432 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guangzhou Orcl Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000039222
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (6)
- EUDAMED 16771a65-4dfc-4ebe-8846-f3f4c348281b 61 fields · synced Aug 2, 2026
- EUDAMED cd3173fd-11da-4d90-be24-88cecc50692d 61 fields · synced May 16, 2026
- EUDAMED 604e2e1a-2acc-46dd-b6a3-5b87650ec847 61 fields · synced May 16, 2026
- EUDAMED 530216fb-7c20-4624-b9e9-e91d7338cd8e 61 fields · synced May 17, 2026
- EUDAMED dd539d86-3357-4c70-94e3-519987285c20 61 fields · synced May 18, 2026
- EUDAMED 41d7ae7a-0c4b-42ef-bac2-34efb26903e5 61 fields · synced May 19, 2026