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Heka
EUDAMEDClass I (EU MDR)
Ref WI1000-2Ref TR0040-2Ref VA0102Ref HD0805Ref TR0390Ref OT0029Ref OT0219Ref TR0399Ref TR0066M1-1Ref WI0621TRRef VA0703Ref TR0503Ref WI0626-1Ref TR0510NAV-1Ref TR0066M3-1Ref WA4028Ref HA0503Ref WI0613Ref WI0618-1Ref OT0951Ref HD0920Ref OT0003Ref TR0510-1Ref OT0200-2Ref OT0005Ref TR0048Ref TR0091Ref VA0103Ref HD0806Ref WI0614-1Ref OT0950-1Ref OT0951-1Ref WI0625-1Ref WI0142-1Ref OT0088Ref WI0146-1Ref HD0701Ref OT0310-2Ref WI0800Ref HD0608Ref OT0220-1Ref HD0600Ref HD0510Ref WA4035-1Ref TR0066-2Ref TR0315-1Ref OT0950Ref OT0952Ref WA4031-1Ref HA8001-2Ref OT0200-1Ref TR0099Ref TR0011-2Ref HD0911Ref VA0105Ref TR0010-2Ref OT0216
Identity
- Trade Name
- Heka EUDAMEDHeka Haft EUDAMED
- Device Name
- Heka Compression box EUDAMEDHeka First Aid EUDAMEDOintment Dressing EUDAMEDBandages EUDAMEDMaternity pad and Underpad EUDAMEDStretch pants EUDAMEDCotton Wool EUDAMEDRescue Blanket EUDAMEDGloves EUDAMEDAlcohol preps EUDAMEDHeka cold / hot pack EUDAMEDNet and Tubular bandages EUDAMEDScissors, tweezer and safety pins EUDAMEDTape EUDAMEDTriangular Bandage EUDAMEDResuscitation Cloth EUDAMED
- Model / Reference
- WI1000-2 EUDAMEDTR0040-2 EUDAMEDVA0102 EUDAMEDHD0805 EUDAMEDTR0390 EUDAMEDOT0029 EUDAMEDOT0219 EUDAMEDTR0399 EUDAMEDTR0066M1-1 EUDAMEDWI0621TR EUDAMEDVA0703 EUDAMEDTR0503 EUDAMEDWI0626-1 EUDAMEDTR0510NAV-1 EUDAMEDTR0066M3-1 EUDAMEDWA4028 EUDAMEDHA0503 EUDAMEDWI0613 EUDAMEDWI0618-1 EUDAMEDOT0951 EUDAMEDHD0920 EUDAMEDOT0003 EUDAMEDTR0510-1 EUDAMEDOT0200-2 EUDAMEDOT0005 EUDAMEDTR0048 EUDAMEDTR0091 EUDAMEDVA0103 EUDAMEDHD0806 EUDAMEDWI0614-1 EUDAMEDOT0950-1 EUDAMEDOT0951-1 EUDAMEDWI0625-1 EUDAMEDWI0142-1 EUDAMEDOT0088 EUDAMEDWI0146-1 EUDAMEDHD0701 EUDAMEDOT0310-2 EUDAMEDWI0800 EUDAMEDHD0608 EUDAMEDOT0220-1 EUDAMEDHD0600 EUDAMEDHD0510 EUDAMEDWA4035-1 EUDAMEDTR0066-2 EUDAMEDTR0315-1 EUDAMEDOT0950 EUDAMEDOT0952 EUDAMEDWA4031-1 EUDAMEDHA8001-2 EUDAMEDOT0200-1 EUDAMEDTR0099 EUDAMEDTR0011-2 EUDAMEDHD0911 EUDAMEDVA0105 EUDAMEDTR0010-2 EUDAMEDOT0216 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08715886027264 EUDAMED08715886027165 EUDAMED08715886006191 EUDAMED08715886003251 EUDAMED08715886024966 EUDAMED08715886024041 EUDAMED08715886021323 EUDAMED08715886030370 EUDAMED08715886030585 EUDAMED08715886023198 EUDAMED08715886011386 EUDAMED08715886029701 EUDAMED08715886028353 EUDAMED08715886030097 EUDAMED08715886027202 EUDAMED08715886005866 EUDAMED08715886005989 EUDAMED08715886029503 EUDAMED08715886028285 EUDAMED08715886017609 EUDAMED08715886018798 EUDAMED08715886020449 EUDAMED08715886030325 EUDAMED08715886028070 EUDAMED08715886020456 EUDAMED08715886020395 EUDAMED08715886029411 EUDAMED08715886006221 EUDAMED08715886003299 EUDAMED08715886028155 EUDAMED08715886026540 EUDAMED08715886026557 EUDAMED08715886028322 EUDAMED08715886002483 EUDAMED08715886018576 EUDAMED08715886002544 EUDAMED08715886006351 EUDAMED08715886028605 EUDAMED08715886019795 EUDAMED08715886025673 EUDAMED08715886021255 EUDAMED08715886005569 EUDAMED08715886013281 EUDAMED08715886026717 EUDAMED08715886030066 EUDAMED08715886026847 EUDAMED08715886017579 EUDAMED08715886017630 EUDAMED08715886026687 EUDAMED08715886011249 EUDAMED08715886023174 EUDAMED08715886029435 EUDAMED08715886027301 EUDAMED08715886006610 EUDAMED08715886006252 EUDAMED08715886027097 EUDAMED08715886021590 EUDAMED
- Basic UDI-DI
- 8715886Compressiebox3G EUDAMED8715886VerbandkofferPT EUDAMED8715886EngelsPlukselCM EUDAMED8715886WindselsDF EUDAMED8715886KraamEnOnderlegUV EUDAMED8715886StretchBroekjeDG EUDAMED8715886Watten67 EUDAMED8715886ReddingsDeken4S EUDAMED8715886Handschoenen7W EUDAMED8715886AlcoholPadXJ EUDAMED8715886PPHotColdPackRT EUDAMED8715886BuisNetVerbandA4 EUDAMED8715886ScharPincetSpeld9K EUDAMED8715886TapeME EUDAMED8715886DriekanteDoek9E EUDAMED8715886BeademingsdoekjeUJ EUDAMED
- Unit of Use DI
- 08715886020432 EUDAMED08715886011362 EUDAMED08715886029497 EUDAMED08715886028261 EUDAMED08715886018781 EUDAMED08715886028056 EUDAMED08715886003282 EUDAMED08715886028148 EUDAMED08715886021293 EUDAMED08715886021309 EUDAMED08715886002476 EUDAMED08715886002537 EUDAMED08715886021606 EUDAMED08715886019931 EUDAMED08715886025666 EUDAMED08715886013274 EUDAMED08715886026700 EUDAMED08715886026670 EUDAMED08715886021248 EUDAMED
- EMDN Code
- M030499 ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER EUDAMEDM9099 GENERAL AND SPECIALIST MEDICAL DEVICES – OTHER (SUTURE PATCHES SEE H900102) EUDAMEDM03030202 SKIN PROTECTIVE BANDAGES EUDAMEDV9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMEDM0303010101 ELASTIC FIXING BANDAGES, NON-ADHESIVE, EXTENSIBLE IN ONE DIRECTION EUDAMEDM040201 ABSORBENT DRESSINGS WITH CELLULOSE PAD AND NON-WOVEN WRAPS EUDAMEDM0304010202 ELASTIC COMPRESSION BANDAGES, COHESIVE, MEDIUM EXTENSIBILITY (70-140%) EUDAMEDM01020202 SYNTHETIC WOOL WADDING NON-RUBBERISED EUDAMEDT030399 HEATING COVERS - OTHER EUDAMEDM0304010102 ELASTIC COMPRESSION BANDAGES, NON-ADHESIVE, MEDIUM EXTENSIBILITY (70-140%) EUDAMEDT01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMEDM010102,M010103 EUDAMEDM010102 PURE COTTON EUDAMEDM030402010101 ELASTIC SUPPORT BANDAGES, NON-ADHESIVE, EXTENSIBLE IN ONE DIRECTION, HIGH EXTENSIBILITY EUDAMEDD0702 ISOPROPYL ALCOHOL FOR THE DISINFECTION OF MEDICAL DEVICES EUDAMEDM9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMEDM03030103 TUBULAR NET BANDAGES EUDAMEDL01040102 SCISSORS FOR BANDAGES, REUSABLE EUDAMEDM0599 MEDICAL PLASTERS - OTHER EUDAMEDM030501 IMMOBILISATION BANDAGES FOR SHOULDER, ARM AND COLLARBONE EUDAMEDT0399 PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER EUDAMEDT010299 EXAMINATION / TREATMENT GLOVES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
- Medical Purpose
- The HEKA compression box contains a complete package containing the main products for the treatment of patients with venous insufficiency who start ambulatory compression therapy. EUDAMEDThe First Aid Kit, supplied as a system / procedure pack, is intended for the immediate and temporary management of minor injuries. Its medical purpose is to enable basic first aid actions such as cleaning wounds, absorbing blood or exudate, covering and protecting minor cuts, abrasions, blisters, and superficial burns, and providing basic support or fixation. The system combines essential first aid components in an organised and accessible manner to support prompt initial response in non‑clinical environments. EUDAMEDThe HEKA cold / hot pack is a reusable cold / hot compress, including protective cover. EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDEUDAMED
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
Category: Compression/pressure sock/stocking, reusable
Heka by Allion BV h.o.d.n. van Heek Medical — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Compression/pressure sock/stocking, reusable.
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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 | 8715886Compressiebox3G | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Allion BV h.o.d.n. van Heek Medical
- EUDAMED SRN
- NL-PR-000015343
Sources (57)
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