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Endobronchial Tube
EUDAMEDClass IIa (EU MDR)
Ref 91070006Model Left 41FrRef 91070009Model Right:35FrRef 91070012Model Right:41FrRef 91070003Model Left 35FrRef 91070001Model Left 28FrRef 91070002Model Left 32FrRef 91070010Model Right:37FrRef 91070005Model Left 39Fr
Identity
- Trade Name
- Endobronchial Tube EUDAMED
- Device Name
- Endobronchial Tube EUDAMED
- Model / Reference
- Left 41Fr EUDAMED91070006 EUDAMEDRight:35Fr EUDAMED91070009 EUDAMEDRight:41Fr EUDAMED91070012 EUDAMEDLeft 35Fr EUDAMED91070003 EUDAMEDLeft 28Fr EUDAMED91070001 EUDAMEDLeft 32Fr EUDAMED91070002 EUDAMEDRight:37Fr EUDAMED91070010 EUDAMEDLeft 39Fr EUDAMED91070005 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972745360654 EUDAMED06972745360685 EUDAMED06972745360715 EUDAMED06972745360623 EUDAMED06972745360609 EUDAMED06972745360616 EUDAMED06972745360692 EUDAMED06972745360647 EUDAMED
- Basic UDI-DI
- B-06972745360654 EUDAMEDB-06972745360685 EUDAMEDB-06972745360715 EUDAMEDB-06972745360623 EUDAMEDB-06972745360609 EUDAMEDB-06972745360616 EUDAMEDB-06972745360692 EUDAMEDB-06972745360647 EUDAMED
- EMDN Code
- R01040299 ENDOBRONCHIAL TUBES, LEFT - OTHER EUDAMEDR01040199 ENDOBRONCHIAL TUBES, RIGHT - OTHER 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
Endobronchial Tube by Guangzhou Orcl Medical Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06972745360654 | 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 (8)
- EUDAMED 955d47ee-27b8-460c-84ec-c9f318bb824c 61 fields · synced Oct 6, 2026
- EUDAMED 5204626c-533a-4eb7-a8d0-6c3eddf223e5 61 fields · synced May 16, 2026
- EUDAMED 46516523-61c2-4feb-b43a-5c709c9272d0 61 fields · synced May 16, 2026
- EUDAMED 8df71842-0b9c-4bec-8181-eed24b2ee84e 61 fields · synced May 16, 2026
- EUDAMED 48ee2a0c-5134-4e3c-8a03-a1fc21991ab0 61 fields · synced May 17, 2026
- EUDAMED fedb8f6e-e94a-4bbf-9f3a-bee8c2eb4f33 61 fields · synced May 17, 2026
- EUDAMED a33d7d01-c1a9-407d-9d9c-48f5b01e7260 61 fields · synced May 18, 2026
- EUDAMED 21dc0f1c-d848-4993-9948-705698860fd5 61 fields · synced May 18, 2026