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EncorePro2
EUDAMEDFDA UDIClass I (EU MDR)
Ref 1054785Model EncorePro2 Patient Management Software
Identity
- Trade Name
- EncorePro2 EUDAMEDFDA UDI
- Generic Name
- Medical equipment clinical data interfacing software FDA UDI
- Device Name
- Encore Pro 2, Patient Management Software (DVD) FDA UDI
- Model / Reference
- EncorePro2 Patient Management Software EUDAMED1054785 EUDAMEDEncore Pro Patient Management Software - 2 FDA UDI
- Description
- Encore Pro 2, Patient Management Software (DVD) FDA UDI
Identifiers
- Catalog Number
- 1054785 FDA UDI
- Primary DI / UDI-DI
- 00606959053793 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959053793 EUDAMED
- FDA Product Code
- MNS FDA UDIBZD FDA UDIMNT FDA UDI
- EMDN Code
- Z11069001 BIOIMAGING PROCESSORS EUDAMED
- GMDN Term
- Medical equipment clinical data interfacing software FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5895 FDA UDI868.5905 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
EncorePro2 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-00606959053793 | 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 e8b09f5f-ac1f-463b-8abe-f45e75990e48 61 fields · synced Jun 19, 2026
- FDA UDI 790cdb2f-0148-4b4b-b004-0175700192f6 34 fields · synced May 30, 2026
- EUDAMED c3c96800-16f2-4c53-8e43-aedc91e983f5 61 fields · synced Jun 19, 2026