Identity
- Trade Name
- EasyPass EUDAMEDFDA UDI
- Generic Name
- Suturing unit, single-use FDA UDI
- Device Name
- Suture Passers EUDAMEDEasyPass Suture Passers, Lasso,standard FDA UDISuture Passers,Needle,190mm FDA UDI
- Model / Reference
- 810503400 EUDAMEDFDA UDI810501600 EUDAMEDFDA UDI
- Description
- EasyPass Suture Passers, Lasso,standard FDA UDISuture Passers,Needle,190mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973877666904 EUDAMED06973877665389 EUDAMED16973877666901 FDA UDI16973877665386 FDA UDI
- Basic UDI-DI
- 697387766RD032100400WE EUDAMED
- FDA Product Code
- HWQ FDA UDI
- EMDN Code
- K030205 ARTHROSCOPY SUTURE DEVICES NOT INCLUDED IN OTHER CLASSES, SINGLE-USE EUDAMED
- GMDN Term
- Suturing unit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Spain EUDAMEDGreece 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Suturing unit, single-use
EasyPass by Hangzhou Rejoin Mastin Medical Device Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou Rejoin Mastin Medical Device Co., Ltd.
Sources (4)
- FDA UDI 2f0e52e0-6c90-49e5-9747-a7c540edce75 33 fields · synced Aug 1, 2026
- FDA UDI 0d2e0b22-1606-40d0-b306-6e9b1774a2d8 33 fields · synced May 30, 2026
- EUDAMED 25b31d90-c888-4e0a-b14f-bd875fdf1782 61 fields · synced Jul 16, 2026
- EUDAMED ebe52e62-6e2a-4329-a02f-4d61e6d4fc84 61 fields · synced Aug 1, 2026