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Spiro
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 740-25KModel 740Ref 711-1KModel 711Ref 703-2KModel 703Ref 710-1KModel 710
Identity
- Trade Name
- SPIRO EUDAMEDFDA UDI
- Generic Name
- Tracheostomy tube speech valve FDA UDI
- Device Name
- Filter EUDAMEDSpeaking Valve EUDAMEDShower Protector for Humidifier EUDAMEDSpeaking Valve with oxygen nipple EUDAMEDSPIRO Adapter (transparent) 13mm for SPIRO 702, 710, 710R and 711 to connect to a non ISO 15 tapered connector FDA UDI
- Model / Reference
- 740 EUDAMED740-25K EUDAMED711 EUDAMED711-1K EUDAMED703 EUDAMED703-2K EUDAMED710 EUDAMED710-1K EUDAMED707 FDA UDI
- Description
- SPIRO Adapter (transparent) 13mm for SPIRO 702, 710, 710R and 711 to connect to a non ISO 15 tapered connector FDA UDI
Identifiers
- Catalog Number
- 707-10 FDA UDI
- Primary DI / UDI-DI
- 27350061230173 EUDAMED27350061230135 EUDAMED47350061230221 EUDAMED27350061230074 EUDAMED27350061230227 EUDAMED07350061231084 FDA UDI
- Basic UDI-DI
- B-27350061230173 EUDAMED73500612300677 EUDAMED7350061230026X EUDAMEDB-27350061230074 EUDAMED
- Unit of Use DI
- 07350061231305 EUDAMED
- 510(k) Number
- K122932 FDA UDI
- FDA Product Code
- JOH FDA UDI
- EMDN Code
- R040201,R900680 EUDAMEDR90060202 PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE EUDAMEDR040201 TRACHEOSTOMY HUMIDIFIERS EUDAMED
- GMDN Term
- Tracheostomy tube speech valve FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5800 FDA UDI
- Market of Registration
- Sweden EUDAMEDGermany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tracheostomy tube speech valve
Spiro by Fogless International AB — Class II — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy tube speech valve.
- Provox Life BasePlate Adaptor — Atos Medical AB · Class I
- Nonventilatory nebulizer(atomizer)(JR-CA007-02) — Xiamen Junrong Medical Equipment Co., Ltd. · Class I
- nonventilatory nebulizer(atomizer)(JR-CA007-03) — Xiamen Junrong Medical Equipment Co., Ltd. · Class I
- InHealth Technologies; Blom-Singer® — FREUDENBERG MEDICAL, LLC · Class II
- Montgomery® Tracheostomy Speaking Valve — Boston Medical Products, Inc. · Class II
- Connector — VADI Medical Technology Co., Ltd. · Class IIb
- Humidification Chamber, Infant — BESMED HEALTH BUSINESS CORP. · Class IIa
- Patient Interfaces（Nasal Cannula） — Shenzhen Lifotronic Technology Co., Ltd. · Class IIa
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Fogless International AB
Sources (6)
- FDA UDI caf93e55-f94d-4625-abd3-6c06fe07b379 37 fields · synced Aug 3, 2026
- EUDAMED e34d1266-1ef1-4c16-a37d-b44c0a9e181a 61 fields · synced Jul 10, 2026
- EUDAMED 1b264186-ecba-45ae-855c-ab0f79c13456 61 fields · synced Jul 16, 2026
- EUDAMED d3f07ee2-7676-43b7-ac66-6cb052212021 61 fields · synced Jul 16, 2026
- EUDAMED d7ef0593-f0c5-4a6a-9f05-279b4c3b4bcf 61 fields · synced Jul 17, 2026
- EUDAMED dfd5ca73-1cc1-4f9d-aae6-dd20c3b85e8c 61 fields · synced Aug 3, 2026