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Guedel Airways for Single Use
EUDAMEDClass IIa (EU MDR)
Ref specification 6Ref specification 3Ref specification 9Ref specification 10Ref specification 5Ref specification 12Ref specification 8
Identity
- Trade Name
- Guedel Airways for Single Use EUDAMED
- Device Name
- NO EUDAMED
- Model / Reference
- specification 6 EUDAMEDspecification 3 EUDAMEDspecification 9 EUDAMEDspecification 10 EUDAMEDspecification 5 EUDAMEDspecification 12 EUDAMEDspecification 8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16970531333278 EUDAMED06970531333219 EUDAMED06970531333318 EUDAMED16970531333322 EUDAMED16970531333315 EUDAMED16970531333216 EUDAMED06970531333325 EUDAMED06970531333257 EUDAMED06970531333349 EUDAMED06970531333301 EUDAMED16970531333254 EUDAMED
- Basic UDI-DI
- 697053133gasuX8 EUDAMED
- Direct Marketing DI
- 16970531333278 EUDAMED06970531333219 EUDAMED06970531333318 EUDAMED16970531333322 EUDAMED16970531333315 EUDAMED16970531333216 EUDAMED06970531333325 EUDAMED06970531333257 EUDAMED06970531333349 EUDAMED06970531333301 EUDAMED16970531333254 EUDAMED
- EMDN Code
- R010102 GUEDEL AIRWAY TUBES EUDAMED
Classification
- Device Class
- Class IIa 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Guedel Airways for Single Use by Shaoxing Undis Medical Technology 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 | 697053133gasuX8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shaoxing Undis Medical Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000002187
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (11)
- EUDAMED 50c2e5d1-cc18-49d3-8dd4-817458b11ec1 61 fields · synced Oct 5, 2026
- EUDAMED f5621fd4-0404-4fab-8374-37a2c7e2a449 61 fields · synced May 16, 2026
- EUDAMED 6655d5ae-bcb9-485f-ad12-069e673d92ed 61 fields · synced May 17, 2026
- EUDAMED 8aa92df7-d8f6-4e34-9124-3c43f9de404a 61 fields · synced May 17, 2026
- EUDAMED 1a1f60c0-d767-4e4b-82ae-905e6b36ec9e 61 fields · synced May 17, 2026
- EUDAMED 4361129f-4d1d-41cc-b968-0e05fd056adc 61 fields · synced May 17, 2026
- EUDAMED 2d6dee2f-9b64-4186-acf9-b16d09431e33 61 fields · synced May 17, 2026
- EUDAMED e90b9353-0849-4706-9a07-5f9e9c39b695 61 fields · synced May 18, 2026
- EUDAMED 1bddbfae-5509-48bb-98a2-8c8c9f23cfd4 61 fields · synced May 18, 2026
- EUDAMED 5b4464d5-9139-4b69-b250-9a1eb9031bc5 61 fields · synced May 19, 2026
- EUDAMED 5815ecf8-463f-4cb7-b15d-80f9d5424a4d 61 fields · synced May 19, 2026