Identity
- Trade Name
- SEW-EASY® 3.5mm DEVICE KIT EUDAMEDSEW-EASY® FDA UDI
- Generic Name
- Suturing unit, single-use FDA UDI
- Device Name
- SEW-EASY® 3.5mm DEVICE KIT EUDAMEDSEW-EASY® DEVICE KIT, 3.5mm FDA UDI
- Model / Reference
- 022201 EUDAMEDFDA UDI
- Description
- SEW-EASY® DEVICE KIT, 3.5mm FDA UDI
Identifiers
- Catalog Number
- 022201 FDA UDI
- Primary DI / UDI-DI
- 00850200006520 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850200006SEW-EASY68 EUDAMED
- FDA Product Code
- DWS FDA UDI
- EMDN Code
- H9099 SUTURE DEVICES - OTHER EUDAMED
- GMDN Term
- Suturing unit, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 870.4500 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
SEW-EASY® 3.5mm DEVICE KIT by LSI Solutions, Inc. — 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 | 0850200006SEW-EASY68 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- LSI SOLUTIONS, Inc.
- EUDAMED SRN
- US-MF-000008267
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 7d35164c-80f5-400e-a69d-3f4e67025662 61 fields · synced Jun 19, 2026
- FDA UDI 8e4eea57-1f79-405b-b69e-1bfb285f2d86 35 fields · synced May 30, 2026