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SEIRIN Acupuncture Needles
EUDAMEDClass IIa (EU MDR)
Ref B-Type No.5(0.25)x30mm
Identity
- Trade Name
- SEIRIN Acupuncture Needles EUDAMED
- Device Name
- SEIRIN Acupuncture Needles EUDAMED
- Model / Reference
- B-Type No.5(0.25)x30mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04547248011390 EUDAMED
- Basic UDI-DI
- 4547248SAN001RZ EUDAMEDB-04547248011390 EUDAMED
- Unit of Use DI
- 24547248011394 EUDAMED
- EMDN Code
- A019002 ACUPUNCTURE NEEDLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
SEIRIN Acupuncture Needles by Seirin Corporation — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 4547248SAN001RZ | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4547248SAN001RZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Seirin Corporation
- EUDAMED SRN
- JP-MF-000012274
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED e54ad597-1e36-42e6-8b24-c2da597d7731 61 fields · synced Jul 27, 2026
- EUDAMED be45d5bc-ed2f-41c7-aef4-deb79b300acd 61 fields · synced May 17, 2026