Identity
- Trade Name
- Diathrive EUDAMEDDiathrive HEALTH Insulin Pen Needle FDA UDI
- Generic Name
- Autoinjector needle FDA UDI
- Device Name
- Insulin Pen Needles EUDAMEDThe products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length. The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1. FDA UDI
- Model / Reference
- IPN-32-4 EUDAMED31*8 EUDAMEDIPN-31-8 FDA UDI
- Description
- The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length. The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975965297236 EUDAMEDFDA UDI
- Basic UDI-DI
- 697122740IPNPZ EUDAMED
- Unit of Use DI
- 86975965297232 EUDAMED
- FDA Product Code
- FMI FDA UDI
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
- GMDN Term
- Autoinjector needle FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5570 FDA UDI
- Market of Registration
- Sweden 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Diathrive by Promisemed Hangzhou Meditech Co., Ltd. — Class IIa — 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 | 697122740IPNPZ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Promisemed Hangzhou Meditech Co., Ltd.
- EUDAMED SRN
- CN-MF-000008465
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 64730767-6f54-4d06-a94c-ad22a7cfce9c 61 fields · synced Oct 6, 2026
- FDA UDI 9886ed74-77c7-47a5-9cc2-9e1ddc2a82bf 33 fields · synced May 30, 2026