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Mallet
EUDAMEDClass I (EU MDR)
Ref 15-1130-10Ref 15-0144-34Ref 8-800 E-47Ref 16-2051-20Ref 16-2041-15Ref 15-0010-55Ref 15-1130-25Ref 15-1130-12Ref 15-3373-23Ref 16-5014-35Ref 15-1130-06Ref 75-2119-00Ref 16-0150-17Ref 15-1130-20Ref 15-3116-65Ref 15-2027-50Ref 16-0150-14Ref 75-2119-01Ref 16-0150-19
Identity
- Device Name
- Mallet EUDAMED
- Model / Reference
- 15-1130-10 EUDAMED15-0144-34 EUDAMED8-800 E-47 EUDAMED16-2051-20 EUDAMED16-2041-15 EUDAMED15-0010-55 EUDAMED15-1130-25 EUDAMED15-1130-12 EUDAMED15-3373-23 EUDAMED16-5014-35 EUDAMED15-1130-06 EUDAMED75-2119-00 EUDAMED16-0150-17 EUDAMED15-1130-20 EUDAMED15-3116-65 EUDAMED15-2027-50 EUDAMED16-0150-14 EUDAMED75-2119-01 EUDAMED16-0150-19 EUDAMED
Identifiers
- Primary DI / UDI-DI
- *+D106151130100U* EUDAMED*+D106150144340/* EUDAMED*+D1068800E470G* EUDAMED*+D106162051200Z* EUDAMED*+D106162041150_* EUDAMED*+D106150010550Z* EUDAMED*+D106151130250-* EUDAMED*+D106151130120W* EUDAMED*+D1061533732302* EUDAMED*+D1061650143500* EUDAMED*+D106151130060Z* EUDAMED*+D1067521190000* EUDAMED*+D106160150170$* EUDAMED*+D106151130200V* EUDAMED*+D1061531166503* EUDAMED*+D106152027500/* EUDAMED*+D106160150140-* EUDAMED*+D1067521190101* EUDAMED*+D106160150190+* EUDAMED
- Basic UDI-DI
- ++D106ORTHOPEDICSRB EUDAMED
- EMDN Code
- L090401 ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE EUDAMEDL0903 ORTHOPAEDIC SURGERY HAMMERS, REUSABLE EUDAMEDL090901 BONE CUTTERS, REUSABLE EUDAMEDL091303 BONE REDUCTION FORCEPS, REUSABLE EUDAMEDL14050101 BONE SURGERY HOOKS, REUSABLE EUDAMEDL091301 BONE GRASPS, REUSABLE EUDAMEDL26 SURGICAL SCREWDRIVERS, REUSABLE EUDAMEDL090403 ORTHOPAEDIC SURGERY GOUGES, REUSABLE EUDAMEDL0901 ORTHOPAEDIC SURGERY SPOONS AND CURETTES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Mallet by ABI Enterprises — Class I — 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 | ++D106ORTHOPEDICSRB | Class I | Active |
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Manufacturer
- Manufacturer
- ABI Enterprises
- EUDAMED SRN
- PK-MF-000035328
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (19)
- EUDAMED 80099d8e-57b4-4144-b6b9-08b5b786de32 61 fields · synced Sep 30, 2026
- EUDAMED d54dfa86-f619-4449-8a06-2f0a008e23ec 61 fields · synced May 11, 2026
- EUDAMED c0b740df-3353-4282-8e46-579907bd7fd1 61 fields · synced May 16, 2026
- EUDAMED 4a79f452-2fe0-4c7f-93e2-66ba2c6a7593 61 fields · synced May 16, 2026
- EUDAMED 462646ad-af20-4bac-80cc-58533cad6a11 61 fields · synced May 16, 2026
- EUDAMED c4c5cd82-3fe3-4bf7-9081-0aababd2caf6 61 fields · synced May 17, 2026
- EUDAMED 98481d04-4c16-487b-bea2-ab000cd3bb56 61 fields · synced May 17, 2026
- EUDAMED 824accf8-7abe-4a99-9390-19bf88cad230 61 fields · synced May 17, 2026
- EUDAMED 040091f1-aec1-404b-bd5e-9ca997cb6e0d 61 fields · synced May 17, 2026
- EUDAMED 65ab34c4-e199-4b23-b2d7-2b6ee8f245fc 61 fields · synced May 17, 2026
- EUDAMED 8317022c-5c8c-4eec-b10b-55f662b5eee7 61 fields · synced May 17, 2026
- EUDAMED ec88ba27-9792-44a7-9c01-85aba52e3d58 61 fields · synced May 17, 2026
- EUDAMED 8bd3f832-aa55-4ed6-b0fb-db2e27e254ad 61 fields · synced May 17, 2026
- EUDAMED 322f99c4-415d-418b-9fa3-ea415327ce03 61 fields · synced May 17, 2026
- EUDAMED 86e043d8-cda7-4407-9e39-77f32ccb6806 61 fields · synced May 18, 2026
- EUDAMED 1ce4bd9b-36e8-4c53-aa0e-e014b64b332d 61 fields · synced May 18, 2026
- EUDAMED 2edc751f-0165-4c9a-b512-8fa380b4c18a 61 fields · synced May 18, 2026
- EUDAMED 6fc7520b-92d8-44b6-b958-2e136c328c21 61 fields · synced May 19, 2026
- EUDAMED 78bb0b05-62a8-411d-ab73-eab4d3350d2c 61 fields · synced May 19, 2026