Filter/HME TwinStar 9 Plus
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Filter/HME TwinStar 9 Plus EUDAMEDFDA UDI
- Generic Name
- Heat/moisture exchanger/microbial medical gas filter FDA UDI
- Model / Reference
- MP05820 EUDAMEDFDA UDI2080436K19S050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675665908 EUDAMEDFDA UDI
- Basic UDI-DI
- 0404867512080436K19S050SH EUDAMED
- 510(k) Number
- K221836 FDA UDI
- FDA Product Code
- CAH FDA UDI
- EMDN Code
- R040102 ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS EUDAMED
- GMDN Term
- Heat/moisture exchanger/microbial medical gas filter FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5260 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Heat/moisture exchanger/microbial medical gas filter
Filter/HME TwinStar 9 Plus by Drägerwerk AG & Co. KGaA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Heat/moisture exchanger/microbial medical gas filter.
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Cleared under the same submission
K221836 also covers:
- CombiStar Plus Filter + HME HEPA flex — Drägerwerk AG & Co. KGaA
- CombiStar Plus Filter + HME flex — Drägerwerk AG & Co. KGaA
- CombiStar Plus Filter + HME straight — Drägerwerk AG & Co. KGaA
- CombiStar Plus Filter flex — Drägerwerk AG & Co. KGaA
- Filter CareStar 20 Plus — Drägerwerk AG & Co. KGaA
- Filter CareStar 35 Plus — Drägerwerk AG & Co. KGaA
- Filter SafeStar 55 Plus — Drägerwerk AG & Co. KGaA
- Filter SafeStar 60A Plus — Drägerwerk AG & Co. KGaA
- Filter SafeStar 90 Plus — Drägerwerk AG & Co. KGaA
- Filter/HME TwinStar 25 Plus — Drägerwerk AG & Co. KGaA
- Filter/HME TwinStar 55 Plus — Drägerwerk AG & Co. KGaA
- Filter/HME TwinStar 60A Plus — Drägerwerk AG & Co. KGaA
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI 19d1c945-2d58-439d-9636-b8986b9dc14d 33 fields · synced Jul 26, 2026
- EUDAMED ca902121-828c-4664-b10a-5126e168323d 61 fields · synced Jul 26, 2026