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Blom-Singer® 22 Fr Dilator-Sizers (for 20 Fr prostheses)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BE 2052
Identity
- Trade Name
- Blom-Singer® 22 Fr Dilator-Sizers (for 20 Fr prostheses) EUDAMEDInHealth Technologies; Blom-Singer FDA UDI
- Generic Name
- Tracheoesophageal fistula gauge FDA UDI
- Device Name
- Blom-Singer® 22 Fr Dilator-Sizers (for 20 Fr prostheses) EUDAMED
- Model / Reference
- BE 2052 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813307013181 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813307013181 EUDAMED
- FDA Product Code
- KCG FDA UDI
- EMDN Code
- P0280 ENT PROSTHESES- ACCESSORIES EUDAMED
- GMDN Term
- Tracheoesophageal fistula gauge FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Market of Registration
- Netherlands 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Blom-Singer® 22 Fr Dilator-Sizers (for 20 Fr prostheses) by Freudenberg Medical LLC — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-00813307013181 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 ae738cb2-e9c5-4b73-877d-d827e2fa131d 61 fields · synced Sep 18, 2026
- FDA UDI d9114949-6a85-4676-a9cd-696a7cc759df 33 fields · synced May 30, 2026