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EncoreBasic
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1068689Model EncoreBasic Compliance Reporting System
Identity
- Trade Name
- EncoreBasic EUDAMEDFDA UDI
- Generic Name
- Medical equipment clinical data interfacing software FDA UDI
- Device Name
- EncoreBasic Software FDA UDI
- Model / Reference
- EncoreBasic Compliance Reporting System EUDAMED1068689 EUDAMEDEncoreBasic Software - 2 FDA UDI
- Description
- EncoreBasic Software FDA UDI
Identifiers
- Catalog Number
- 1068689 FDA UDI
- Primary DI / UDI-DI
- 00606959046962 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959046962 EUDAMED
- FDA Product Code
- OUG FDA UDI
- EMDN Code
- Z11069001 BIOIMAGING PROCESSORS EUDAMED
- GMDN Term
- Medical equipment clinical data interfacing software FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6310 FDA UDI
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Austria 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
EncoreBasic by Respironics, Inc. — Class I — 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-00606959046962 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (3)
- EUDAMED 6aa9c58c-6523-4fd2-bf8d-dc47e07032f2 61 fields · synced Jul 9, 2026
- FDA UDI c56a4338-4a49-45fd-92b1-4983818657ba 35 fields · synced May 29, 2026
- EUDAMED 1fd651d4-d312-4081-a600-42c731eb2d56 61 fields · synced Jul 9, 2026