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Endotracheal Tube
EUDAMEDClass IIa (EU MDR)
Ref 0535Model Endotracheal TubeRef 0528Ref 0530Ref 7173Ref 7100Ref 7165Ref 7099Ref 7171Ref 7044Ref 7002Ref 7159Ref 7170Ref 7058Ref 7054Ref 7047Ref 7101Ref 7049Ref 0538Ref 7053Ref 7163Ref 7055Ref 0536Ref 7166Ref 7048Ref 0532Ref 7161Ref 7057Ref 7045Ref 7052
Identity
- Trade Name
- Endotracheal Tube EUDAMED
- Device Name
- Endotracheal Tube EUDAMED
- Model / Reference
- Endotracheal Tube EUDAMED0535 EUDAMED0528 EUDAMED0530 EUDAMED7173 EUDAMED7100 EUDAMED7165 EUDAMED7099 EUDAMED7171 EUDAMED7044 EUDAMED7002 EUDAMED7159 EUDAMED7170 EUDAMED7058 EUDAMED7054 EUDAMED7047 EUDAMED7101 EUDAMED7049 EUDAMED0538 EUDAMED7053 EUDAMED7163 EUDAMED7055 EUDAMED0536 EUDAMED7166 EUDAMED7048 EUDAMED0532 EUDAMED7161 EUDAMED7057 EUDAMED7045 EUDAMED7052 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904399105358 EUDAMED08904399105280 EUDAMED08904399105303 EUDAMED08904399171735 EUDAMED08904399171001 EUDAMED08904399171650 EUDAMED08904399170998 EUDAMED08904399171711 EUDAMED08904399170448 EUDAMED08904399170028 EUDAMED08904399171599 EUDAMED08904399171704 EUDAMED08904399170585 EUDAMED08904399170547 EUDAMED08904399170479 EUDAMED08904399171018 EUDAMED08904399170493 EUDAMED08904399105389 EUDAMED08904399170530 EUDAMED08904399171636 EUDAMED08904399170554 EUDAMED08904399105365 EUDAMED08904399171667 EUDAMED08904399170486 EUDAMED08904399105327 EUDAMED08904399171612 EUDAMED08904399170578 EUDAMED08904399170455 EUDAMED08904399170523 EUDAMED
- Basic UDI-DI
- 89043991HSETT014M EUDAMED
- EMDN Code
- R01030201 ENDOTRACHEAL TUBES, CUFFED, NOT REINFORCED EUDAMEDR01030101 ENDOTRACHEAL TUBES, CUFFLESS, NOT REINFORCED EUDAMEDR01030202 ENDOTRACHEAL TUBES, CUFFED, REINFORCED EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Basic endotracheal tube, single-use
Endotracheal Tube by Harsoria Healthcare Pvt. Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Basic endotracheal tube, single-use.
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- Rurka intubacyjna z mankietem — SUMI spółka z ograniczoną odpowiedzialnością spółka komandytowa · Class IIa
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 | 89043991HSETT014M | Class IIa | Active |
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Manufacturer
- Manufacturer
- Harsoria Healthcare Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000018349
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (29)
- EUDAMED 6d3cf01c-db3a-4093-a67a-39a808f523fc 61 fields · synced Aug 5, 2026
- EUDAMED 931aee50-cad0-4580-836d-74a3c6bbd8c0 61 fields · synced May 11, 2026
- EUDAMED 03e3a2db-23b3-4c4a-9cba-0e15148f7a10 61 fields · synced May 11, 2026
- EUDAMED 15652ccd-da4e-42c2-b654-0a462f80a5b6 61 fields · synced May 11, 2026
- EUDAMED db5b8e87-5651-4afa-b361-035b7d25b861 61 fields · synced May 16, 2026
- EUDAMED 9cb319d6-74d3-4dc0-982d-c8e1c5c99eb8 61 fields · synced May 16, 2026
- EUDAMED 75b40f47-ff64-4faa-be12-5c3f10884880 61 fields · synced May 16, 2026
- EUDAMED 6980abab-c83c-4154-8810-d7f91f91e345 61 fields · synced May 16, 2026
- EUDAMED 2960ef18-b415-4438-9c9d-939a28917c03 61 fields · synced May 16, 2026
- EUDAMED 091477ee-4cdc-4de0-8070-24bdc15c7164 61 fields · synced May 17, 2026
- EUDAMED 3a597d3e-97ed-4404-9fac-2dfb2bd6657b 61 fields · synced May 17, 2026
- EUDAMED 4a238267-8153-461e-877b-1f2df53750e5 61 fields · synced May 17, 2026
- EUDAMED 15b9a60d-0f41-4e49-994a-ed5b0c1ec85c 61 fields · synced May 17, 2026
- EUDAMED dce6e019-c54d-4114-861d-a8084b53ea06 61 fields · synced May 17, 2026
- EUDAMED d07406ba-4246-4342-a09e-5754104204ce 61 fields · synced May 17, 2026
- EUDAMED 520567e1-f1b4-4f9d-9123-ac74354f557e 61 fields · synced May 17, 2026
- EUDAMED a9f9fe1f-fa54-4c03-928e-0fcb167d9245 61 fields · synced May 17, 2026
- EUDAMED e7e15b16-774b-473e-8639-ea06918843ec 61 fields · synced May 18, 2026
- EUDAMED 25008904-7745-41ef-9e7e-b229f97187a0 61 fields · synced May 18, 2026
- EUDAMED bced58a8-18dd-440a-b4f9-334295e61e26 61 fields · synced May 18, 2026
- EUDAMED a63dbd5f-237b-4360-b0bd-a6513fcddf16 61 fields · synced May 18, 2026
- EUDAMED ec54003a-19a9-47ee-adc4-9c5542192e5f 61 fields · synced May 18, 2026
- EUDAMED a108d253-0036-4e32-8e6f-5885aa3b4105 61 fields · synced May 18, 2026
- EUDAMED 08cd4690-104a-4dc0-b80a-3b46c8b95f4c 61 fields · synced May 18, 2026
- EUDAMED 6f332664-3075-4e2e-a971-6ae5344163bc 61 fields · synced May 19, 2026
- EUDAMED e843e35b-3785-42ce-aa80-a6b077d52022 61 fields · synced May 19, 2026
- EUDAMED 6e9a6b03-c694-4236-a1c5-494436f26aa7 61 fields · synced May 19, 2026
- EUDAMED a7203e02-a1a6-4704-ab48-f608a22d96cf 61 fields · synced May 19, 2026
- EUDAMED 4d352d67-6600-4368-a8ec-6ea8c6e3f351 61 fields · synced May 19, 2026