Identity
- Trade Name
- AccuSert EUDAMEDFDA UDI
- Generic Name
- Injector reset device FDA UDI
- Device Name
- AccuSert EUDAMEDOPTFlow Needle Inserter FDA UDI
- Model / Reference
- FP-0010033 EUDAMEDFDA UDI
- Description
- OPTFlow Needle Inserter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817708022964 EUDAMEDFDA UDI
- Basic UDI-DI
- 081770802NI00122 EUDAMED
- Direct Marketing DI
- 00817708022964 EUDAMED
- 510(k) Number
- K213429 FDA UDI
- FDA Product Code
- KZH FDA UDI
- EMDN Code
- A018003 NEEDLE INTRODUCERS EUDAMED
- GMDN Term
- Injector reset device FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6920 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
AccuSert by EMED Technologies Corporation — 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 | 081770802NI00122 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- EMED Technologies Corporation
- EUDAMED SRN
- US-MF-000012148
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 7c1ef1e9-0676-43f3-9d1a-0aa62c83e2fe 61 fields · synced Jun 20, 2026
- FDA UDI 2e78b37c-b114-4e59-a265-6ab85c1edf3c 34 fields · synced May 29, 2026