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Embro
EUDAMEDClass IIa (EU MDR)
Ref IPN31*4Model IPN-32-4Ref IPN31*5Ref IPN31*8
Identity
- Trade Name
- Embro EUDAMED
- Device Name
- Insulin Pen Needles EUDAMED
- Model / Reference
- IPN-32-4 EUDAMEDIPN31*4 EUDAMEDIPN31*5 EUDAMEDIPN31*8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978111922778 EUDAMED06978111922785 EUDAMED06978111922808 EUDAMED
- Basic UDI-DI
- 697122740IPNPZ EUDAMED
- Unit of Use DI
- 86978111922774 EUDAMED86978111922781 EUDAMED86978111922804 EUDAMED
- EMDN Code
- A0101010202 HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Embro by Promisemed Hangzhou Meditech Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697122740IPNPZ | Class IIa | Active |
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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 (3)
- EUDAMED 412f4256-9b45-482f-a8d6-29a96b9717cc 61 fields · synced Oct 6, 2026
- EUDAMED 7ad31569-457c-4bf7-9796-7825eadec2a7 61 fields · synced May 18, 2026
- EUDAMED 6571300e-e222-431d-97b6-33c8f3df2e28 61 fields · synced May 18, 2026