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EMI Super Micro Needle Holder
EUDAMEDFDA UDIClass I (EU MDR)
Ref EMI087-L15-RR-N-RB-0.3Model Needle Holder
Identity
- Trade Name
- EMI Super Micro Needle Holder EUDAMEDFDA UDI
- Generic Name
- Suturing needle holder, reusable FDA UDI
- Device Name
- EMI Super Micro Needle Holder EUDAMEDThe product is intended to be used for the purpose of grasping the suture needle during suturing. FDA UDI
- Model / Reference
- Needle Holder EUDAMEDEMI087-L15-RR-N-RB-0.3 EUDAMEDEMI087 FDA UDI
- Description
- The product is intended to be used for the purpose of grasping the suture needle during suturing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04582486860973 EUDAMEDFDA UDI
- Basic UDI-DI
- 458248686SMNHPN EUDAMED
- Direct Marketing DI
- 04582486860973 EUDAMED
- FDA Product Code
- FHQ FDA UDI
- EMDN Code
- L1004 MICROSURGERY NEEDLE HOLDERS, REUSABLE EUDAMED
- GMDN Term
- Suturing needle holder, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.4730 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
EMI Super Micro Needle Holder by Emi Factory Co., Ltd. — 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 | 458248686SMNHPN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Emi Factory Co., Ltd.
- EUDAMED SRN
- JP-MF-000025742
- Authorised Representative
- Mitaka Europe GmbH DE-AR-000006361
Sources (2)
- EUDAMED 7fe89e8a-5997-4120-af3f-b8d91871e879 61 fields · synced Jul 9, 2026
- FDA UDI afb14d11-2431-46a5-9e67-94f2573fb1e1 34 fields · synced May 30, 2026