Identity
- Trade Name
- Dorma 200, INTL EUDAMEDDorma FDA UDI
- Generic Name
- Heated respiratory humidifier FDA UDI
- Device Name
- REMstar, REMstar SE, Dorma EUDAMEDDorma 200, International FDA UDI
- Model / Reference
- INV201 EUDAMEDDorma 200, INTL FDA UDI
- Description
- Dorma 200, International FDA UDI
Identifiers
- Catalog Number
- INV201 FDA UDI
- Primary DI / UDI-DI
- 00606959036895 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959036895 EUDAMED
- 510(k) Number
- K130077 FDA UDI
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- Z1203010502 ADULT PULMONARY VENTILATORS EUDAMED
- GMDN Term
- Heated respiratory humidifier FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dorma 200, INTL 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-00606959036895 | 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
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (2)
- EUDAMED 6083992d-b78a-440b-ac57-bc9ccbaa68c6 61 fields · synced Jun 17, 2026
- FDA UDI 34fe1d5d-1aae-4cae-9ecd-7ba5c18aed47 37 fields · synced May 30, 2026