Identity
- Trade Name
- Porte-aiguille EUDAMEDONE FDA UDI
- Generic Name
- Suturing needle holder, single-use FDA UDI
- Device Name
- Porte-aiguille EUDAMED
- Model / Reference
- 17534X10 EUDAMEDONE S-Needle holder X10 FDA UDI
Identifiers
- Catalog Number
- 17534X10 FDA UDI
- Primary DI / UDI-DI
- 03700483622610 EUDAMEDFDA UDI
- Basic UDI-DI
- 37004836Needle-Holders2AS EUDAMED
- FDA Product Code
- HNM FDA UDI
- EMDN Code
- Q0299 OPHTHALMIC DEVICES - OTHER EUDAMED
- GMDN Term
- Suturing needle holder, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Porte-aiguille by Moria S.A. — 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 | 37004836Needle-Holders2AS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Moria S.A.
- EUDAMED SRN
- FR-MF-000000336
Sources (2)
- EUDAMED 8d90b6b1-d189-4402-b313-4f9af719d168 61 fields · synced Jul 31, 2026
- FDA UDI 54beab84-0e03-4765-99ba-584bccdd65b7 33 fields · synced May 30, 2026