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Intubating Stylet
EUDAMEDFDA UDIClass I (EU MDR)
Ref PA1811S02SModel Stylet RigidRef PA1811S02LRef PA180208Model StyletRef PA180214Ref PA1811S02MRef PA182108Ref PA1811R02LRef PA180108Ref PA180114Ref PA180210
Identity
- Trade Name
- Intubating Stylet EUDAMEDIntubating Stylet, Size 14FR, OD 4.7mm FDA UDI
- Generic Name
- Artificial airway stylet, single-use FDA UDI
- Device Name
- Intubating Stylet EUDAMED
- Model / Reference
- Stylet Rigid EUDAMEDPA1811S02S EUDAMEDPA1811S02L EUDAMEDStylet EUDAMEDPA180208 EUDAMEDPA180214 EUDAMEDPA1811S02M EUDAMEDPA182108 EUDAMEDPA1811R02L EUDAMEDPA180108 EUDAMEDPA180114 EUDAMEDFDA UDIPA180210 EUDAMED
Identifiers
- Catalog Number
- PA180114 FDA UDI
- Primary DI / UDI-DI
- 06923310911184 EUDAMED06923310909778 EUDAMED06923310909877 EUDAMED06923310909907 EUDAMED06923310911191 EUDAMED06923310911214 EUDAMED06923310909785 EUDAMED06923310909587 EUDAMED06923310902892 EUDAMEDFDA UDI06923310909884 EUDAMED
- Basic UDI-DI
- 69233109PA18119E EUDAMED69233109PA18019B EUDAMED
- FDA Product Code
- BSR FDA UDI
- EMDN Code
- R018004 INTUBATION DEVICE GUIDES EUDAMED
- GMDN Term
- Artificial airway stylet, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5790 FDA UDI
- Market of Registration
- France EUDAMEDPoland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Intubating Stylet by Hangzhou Formed Medical Devices Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69233109PA18119E | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou Formed Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000011212
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (16)
- EUDAMED 7873bfd8-0bac-44a9-a7de-6f992ec61605 61 fields · synced Sep 18, 2026
- EUDAMED 88e41f08-bc30-4364-a357-77f9e4d76896 61 fields · synced May 17, 2026
- EUDAMED b69159e4-cd14-42be-8f78-bd0c74278dbf 61 fields · synced May 17, 2026
- EUDAMED 58f13e09-fd2b-4c8a-8962-0081b70691c6 61 fields · synced May 17, 2026
- EUDAMED 9b6acadd-3693-4d88-8af8-17739f540f05 61 fields · synced May 17, 2026
- EUDAMED 6923c472-922b-499f-b811-d6fac98c7d25 61 fields · synced May 17, 2026
- EUDAMED a0ef8055-7013-4e7c-9ae5-70728f3aef10 61 fields · synced May 17, 2026
- EUDAMED 21d19fd9-dd08-4604-af7a-d2564e8cffe8 61 fields · synced May 18, 2026
- EUDAMED e5de377d-6179-4fbc-bf03-1ab5496cd062 61 fields · synced May 19, 2026
- EUDAMED 1bddc1d4-8a81-416a-99e5-73498be4514e 61 fields · synced May 19, 2026
- FDA UDI 703a25e6-2414-4cde-b8c3-1765714147b5 33 fields · synced May 24, 2026
- EUDAMED af594d2a-a67c-4734-95db-44a10c9b2a2d 61 fields · synced Jul 9, 2026
- EUDAMED d94aced5-1e7c-4d80-9850-9e75bad67248 61 fields · synced Jul 11, 2026
- EUDAMED b2b3fd94-20aa-4226-9905-fb99e2741013 61 fields · synced Jul 15, 2026
- EUDAMED 19a0b35d-962e-41ed-9ed7-bdec7581bea7 61 fields · synced Jul 26, 2026
- EUDAMED d9569983-acb3-4b28-bd1e-84d22da7a6f5 61 fields · synced Jul 30, 2026