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InnoSpire Go EU2/ROW
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1126560Model InnoSpire Go
Identity
- Trade Name
- InnoSpire Go EU2/ROW EUDAMEDINNOSPIRE GO Europe2ROW FDA UDI
- Generic Name
- Ultrasonic nebulizing system FDA UDI
- Device Name
- INNOSPIRE GO Europe2ROW FDA UDI
- Model / Reference
- InnoSpire Go EUDAMED1126560 EUDAMED00 FDA UDI
- Description
- INNOSPIRE GO Europe2ROW FDA UDI
Identifiers
- Catalog Number
- 1126560 FDA UDI
- Primary DI / UDI-DI
- 00383730004051 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00383730004051 EUDAMED
- 510(k) Number
- K170853 FDA UDI
- FDA Product Code
- CAF FDA UDI
- EMDN Code
- Z12040210 ULTRASONIC NEBULISERS EUDAMED
- GMDN Term
- Ultrasonic nebulizing system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Market of Registration
- Germany 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
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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
InnoSpire Go EU2/ROW by Respironics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00383730004051 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED b9b59985-00aa-4495-b49d-eeaf8e83c9ad 61 fields · synced Jun 18, 2026
- FDA UDI 1ff28cd1-760b-43a1-beaa-ff527ffa3bb2 36 fields · synced May 24, 2026