Identity
- Trade Name
- Americot EUDAMEDFDA UDI
- Generic Name
- Cottonoid pad FDA UDI
- Device Name
- Americot EUDAMEDAmericot Blue 1/4" x 1/4" FDA UDI
- Model / Reference
- 20-01S EUDAMEDFDA UDI
- Description
- Americot Blue 1/4" x 1/4" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10749915000039 EUDAMED20749915000036 FDA UDI
- Basic UDI-DI
- B-10749915000039 EUDAMED
- 510(k) Number
- K854713 FDA UDI
- FDA Product Code
- HBA FDA UDI
- EMDN Code
- M040799 SPECIAL PADS - OTHER EUDAMED
- GMDN Term
- Cottonoid pad FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 882.4700 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Americot by American Surgical Company, LLC — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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-10749915000039 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- American Surgical Company, LLC
- EUDAMED SRN
- US-MF-000007259
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 2669f5c5-353e-4479-a620-cce590c9349f 61 fields · synced Jun 9, 2026
- FDA UDI 46eb31d2-36a6-407a-9375-1430db91d4c3 34 fields · synced May 30, 2026