EMI Super Micro Needle Holder
EUDAMEDFDA UDIClass I (EU MDR)
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-L18-RR-N-S-0.1 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
- 04582486862892 EUDAMEDFDA UDI
- Basic UDI-DI
- 458248686SMNHPN EUDAMED
- Direct Marketing DI
- 04582486862892 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
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The EMI Super Micro Needle Holder is a precision instrument designed for medical professionals to safely and accurately administer medications, particularly in the administration of implants. It features a sturdy base, precise needle guidance, and advanced safety mechanisms. The device ensures sterile conditions by utilizing a gentle suction mechanism.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 7dcf55ac-75aa-4920-a3ca-23bdf4bfd561 61 fields · synced Aug 2, 2026
- FDA UDI 1dce99c4-1848-403c-8bac-6d6e40c4332d 34 fields · synced May 30, 2026