Foam Stoma Protector, White, 2.4''Lx2.0''W (6cm x 5cm) 30 pk
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Foam Stoma Protector,White, 2.4''Lx2.0''W (6cm x 5cm) 30 pk EUDAMEDInHealth Technologies; Blom-Singer FDA UDI
- Generic Name
- Tracheostoma protector, reusable FDA UDI
- Device Name
- FOAMSTOMAPROT EUDAMED
- Model / Reference
- BE 6200 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813307012771 EUDAMEDFDA UDI
- Basic UDI-DI
- 08482530FOAMSTOMAPROT43 EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
- GMDN Term
- Tracheostoma protector, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 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: Pulmonary function analysis system, adult
Foam Stoma Protector, White, 2.4''Lx2.0''W (6cm x 5cm) 30 pk 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 | 08482530FOAMSTOMAPROT43 | 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 0d4be3d1-07a3-4ab4-af23-bdd3d059393c 61 fields · synced Sep 18, 2026
- FDA UDI b22d2bd7-0a03-45e9-bbb9-237c85f69039 33 fields · synced May 30, 2026