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Manipler AZ 35W Disposable Skin Stapler - 783100
EUDAMEDClass IIa (EU MDR)
Ref 783100
by Mani, Inc.
Identity
- Trade Name
- Manipler AZ 35W Disposable Skin Stapler - 783100 EUDAMED
- Device Name
- ManiplerAZ EUDAMED
- Model / Reference
- 783100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04546951616502 EUDAMED
- Basic UDI-DI
- 4546951000010ZA EUDAMED
- EMDN Code
- H02010101 SKIN STAPLERS, SINGLE-USE 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
Manipler AZ 35W Disposable Skin Stapler - 783100 by Mani, Inc. — 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 | 4546951000010ZA | Class IIa | Active |
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Manufacturer
- Manufacturer
- Mani, Inc.
- EUDAMED SRN
- JP-MF-000017860
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 42354c30-978a-4453-a065-873baefbc760 61 fields · synced Jun 18, 2026