HydroFit Hydrocolloid Adhesive Housing, Oval Extra, 30pk
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- HydroFit Hydrocolloid Adhesive Housing, Oval Extra, 30pk EUDAMEDInHealth Technologies; Blom-Singer; Hydrofit FDA UDI
- Generic Name
- Tracheostomy base plate, single-use FDA UDI
- Device Name
- HYDROFIT EUDAMED
- Model / Reference
- BE 6087 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848253003566 EUDAMED00848253003559 FDA UDI
- Basic UDI-DI
- 08482530HYDROFIT73 EUDAMED
- FDA Product Code
- BYD FDA UDI
- EMDN Code
- R9080 RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Tracheostomy base plate, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5375 FDA UDI
- Market of Registration
- Netherlands 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
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Gas-sampling/monitoring respiratory tubing, single-use
HydroFit Hydrocolloid Adhesive Housing, Oval Extra, 30pk by Freudenberg Medical, Llc — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08482530HYDROFIT73 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Freudenberg Medical LLC
- EUDAMED SRN
- US-MF-000023823
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 549b6594-a548-478b-a0de-009955ee3b04 61 fields · synced Sep 18, 2026
- FDA UDI 61d9f143-85fe-4172-8b54-7b3f82516004 33 fields · synced May 30, 2026