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Blom-Singer Replacement Gel Caps, 20 Fr.
EUDAMEDFDA UDIClass I (EU MDR)
Ref BE 3290
Identity
- Trade Name
- Blom-Singer Replacement Gel Caps, 20 Fr. EUDAMEDInHealth Technologies; Blom-Singer FDA UDI
- Generic Name
- Tracheoesophageal device insertion capsule FDA UDI
- Device Name
- GELCAPS EUDAMED
- Model / Reference
- BE 3290 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813307011507 EUDAMEDFDA UDI
- Basic UDI-DI
- 08482530GELCAPSJ6 EUDAMED
- FDA Product Code
- EWL FDA UDI
- EMDN Code
- P0280 ENT PROSTHESES- ACCESSORIES EUDAMED
- GMDN Term
- Tracheoesophageal device insertion capsule FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3730 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Blom-Singer Replacement Gel Caps, 20 Fr. by Freudenberg Medical LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08482530GELCAPSJ6 | 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 834312f3-c01a-44d0-9bbc-91ab1854b8c9 61 fields · synced Jun 18, 2026
- FDA UDI 973f98a4-3477-4e8a-931f-5dfac923dfcf 34 fields · synced May 30, 2026